Important Safety Information

 

CATALYS™ PRECISION LASER SYSTEM

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the CATALYS™ Precision Laser System

 
Rx Only.

Indications

The OptiMedica™ CATALYS™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Contraindications

The CATALYS™ System is contraindicated in patients with corneal ring and/or inlay implants, severe corneal opacities, corneal abnormalities, significant corneal edema or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule, patients younger than 22 years of age, descemetocele with impending corneal rupture, and any contraindications to cataract surgery. 

Warnings

Prior to INTEGRAL GUIDANCE System imaging and laser treatment, the suction ring must be completely filled with sterile buffered saline solution. If any air bubbles and/or a meniscus appear on the video image before treatment, do not initiate laser treatment. Before initiating laser treatment, inspect images created from the OCT data, surface fits, and overlaid pattern in both axial and sagittal views, and review the treatment parameters on the Final Review Screen for accuracy. Safety margins for all incisions are preserved only if Custom Fit Adjustments to ocular surface(s) are applied in accordance with the instructions for use. Purposeful misuse of the Custom Fit Adjustment to ocular surfaces can result in patient injury and complication(s), and therefore must be avoided. Standard continuous curvilinear capsulorrhexis (CCC) surgical technique must be used for surgical removal of the capsulotomy disc. The use of improper capsulotomy disc removal technique may potentially cause or contribute to anterior capsule tear and/or a noncircular, irregularly shaped capsulotomy. Verify that the suction ring is correctly connected to the disposable lens component of the LIQUID OPTICS Interface during the initial patient docking procedure. 

Precautions

The CATALYS™ System has not been adequately evaluated in patients with a cataract greater than Grade 4 (via LOCS III); therefore no conclusions regarding either the safety or effectiveness are presently available. Cataract surgery may be more difficult in patients with an axial length less than 22 mm or greater than 26 mm, and/or an anterior chamber depth less than 2.5 mm due to anatomical restrictions. Use caution when treating patients who may be taking medications such as alpha blockers (e.g. Flomax) as these medications may be related to Intraoperative Floppy Iris Syndrome (IFIS); this condition may include poor preoperative dilation, iris billowing and prolapse, and progress intraoperative miosis. These conditions may require modification of surgical technique such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. Surgical removal of the cataract more than 30 minutes after the laser capsulotomy and laser lens fragmentation has not been clinically evaluated. The clinical effects of delaying surgical removal more than 30 minutes after laser anterior capsulotomy and laser lens fragmentation are unknown. The LIQUID OPTICS Interface is intended for single patient use only. Full-thickness corneal cuts or incisions should be performed with instruments and supplies on standby, to seal the eye in case of anterior chamber collapse or fluid leakage. Patients who will undergo full-thickness corneal incisions with the CATALYS™ System should be given the same standard surgical preparation as used for patients undergoing cataract surgery for the removal of the crystalline lens. During intraocular surgery on patients who have undergone full-thickness corneal incisions with the CATALYS™ System, care should be taken if an eyelid speculum is used, in order to limit pressure from the speculum onto the open eye. Patients who will be transported between the creation of a full-thickness corneal incision and the completion of intraocular surgery should have their eye covered with a sterile rigid eye shield, in order to avoid inadvertent eye injury during transport. Patients must be able to lie flat and motionless in a supine position and able to tolerate local or topical anesthesia. 

Adverse Effects

Complications associated with the CATALYS™ System include mild Petechiae and subconjunctival hemorrhage due to vacuum pressure of the LIQUID OPTICS Interface Suction ring. Potential complications and adverse events generally associated with the performance of capsulotomy and lens fragmentation, or creation of a partial-thickness or full-thickness cut or incision of the cornea, include: Acute corneal clouding, age- related macular degeneration, amaurosis, anterior and/or posterior capsule tear/rupture, astigmatism, capsulorrhexis notch during phacoemulsification, capsulotomy/lens fragmentation or cut/incision decentration, cells in anterior chamber, choroidal effusion or hemorrhage, conjunctival hyperemia/injection/erythema/chemosis, conjunctivitis (allergic/viral), corneal abrasion/depithelization/epithelial defect, corneal edema, cystoid macula edema, Descemet’s detachment, decentered or dislocated intraocular lens implant, diplopia, dropped or retained lens, dry eye/superficial punctate keratitis, edema, elevated intraocular pressure, endothelial decompensation, floaters, glaucoma, halo, inflammation, incomplete capsulotomy, intraoperative floppy iris syndrome, iris atrophy/extrusion, light flashes, meibomitis, ocular discomfort (e.g., pain, irritation, scratchiness, itching, foreign body sensation), ocular trauma, petechiae, photophobia, pigment changes/pigment in corneal endothelium/foveal region, pingueculitis, posterior capsule opacification, posterior capsule rupture, posterior vitreous detachment, posteriorly dislocated lens material, pupillary contraction, red blood cells in the anterior chamber (not hyphema), residual cortex, retained lens fragments, retinal detachment or hemorrhage, scar in Descemet’s membrane, shallowing or collapsing of the anterior chamber, scoring of the posterior corneal surface, snailtrack on endothelium, steroid rebound effect, striae in Descemet’s, subconjunctival hemorrhage, thermal injury to adjacent eye tissues, toxic anterior shock syndrome, vitreous in the anterior chamber, vitreous band or loss, wound dehiscence, wound or incision leak, zonular dehiscence.

Caution

Federal law (USA) restricts this device to sale by or on the order of a physician. The system should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified.

Attention

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

COMPACT INTUITIV™ System

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV™ SYSTEM

Rx Only

INDICATIONS

The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV™ System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

READ THE FOLLOWING SAFETY PRECAUTIONS AND WARNINGS CAREFULLY BEFORE YOU USE THE SYSTEM IN SURGERY

Do not use extension cords with your machine.
Do not overload your AC electrical outlet.
If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call Johnson & Johnson Surgical Vision, Inc. customer service to order a new cord.
Do not block the openings as heat build-up can cause system failures that can result in a fire hazard. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation.
Do not block the air fans on the bottom of the console as heat build-up can cause system failures which can result in a fire hazard.
Do not try to roll the system cart on carpets or over objects on the floor such as cables and power cords.
Take care not to trip over the power cords and the foot pedal cords.
Do not place the instrument on uneven or sloped surfaces.
Only use disposables, accessories, or other surgical instruments designed for this system. Use only parts recommended by Johnson & Johnson Surgical Vision, Inc. to achieve the optimum performance and the safety of the system.
Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup.
Do not exceed maximum weight of 25 pounds (11.25 Kg) on the Programmable IV Pole bottle holder.
Do not use more than one IV pole extender with the IV pole.
If there is no IV pole attached to the system, hang the irrigation fluid container at least 77 cm from the patient’s eye.
To protect the patient from contaminated fluids or handpieces, use only:

sterile tubing sets
sterile irrigation fluid
sterile handpieces

Use caution when handling handpiece with sharp edges or pointed tips.
Wrap the excess power cord neatly around the cord wrap on the back of the IV pole or cart.
Always replace the Single-Use Pack and irrigation solution bottle between surgical cases.

Changing Irrigation

Use extreme caution when you lower or raise the irrigation solution bottle to decrease fluid flow or increase fluid flow, and fluid pressure. If you lower the bottle too much it can cause the anterior chamber to collapse or to become too shallow; take care to avoid abrasion of tissues during phacoemulsification. If you raise the bottle too high it can cause the anterior chamber to deepen. Note: Use a new bottle of irrigation solution at the start of each case. Phacoemulsification Without Adequate Irrigation Operating phacoemulsification without an adequate irrigation flow can result in an elevated temperature of the tip and subsequent damage to the eye tissue or could cause the chamber to collapse. Confirm that there is irrigation flow before you initiate phacoemulsification. A tight wound or the angle of the needle next to the wound can also constrict the irrigation flow. Pinching of the coaxial irrigation sleeve assembly on the needle of the phaco handpiece causes the constriction.

Power Failure During Surgery

If there is a loss of power during a procedure, you need to:

Withdraw the handpiece from the eye; and
Release the foot pedal to position 0.

When power is restored:

Select Prime/Tune to reprime the fluids and tune the phaco handpiece. Use Bypass to reduce the length of prime time.
Select the mode that was in use when the system lost power (Phaco, IA, Vitrectomy, or Diathermy).

Connecting Handpieces

It is very important that the electrical connectors on the handpieces are completely dry prior to connecting them to the system receptacles. You may receive a “Phaco Handpiece Error” message if the connector is wet.

Handling the Phaco Handpiece

The phaco handpiece is a very delicate instrument and you must handle the handpiece with EXTREME care. If you drop the handpiece or the handpiece receives any other significant impact, the handpiece might not work properly. The ultrasonic titanium phaco tip must never touch any solid material while in use. Always clear the handpiece of fluid immediately following surgery. See cleaning instructions in Chapter 7 "Care and Cleaning". Handpieces can be extremely hot immediately after sterilization. Use care and caution when handling.

Phaco and Vitrectomy Operation

Do not activate the Phaco and Vitrectomy handpieces with the tips in air as this reduces the useful life of the handpiece and the cutter. When introducing power to the Phaco or Vitrectomy handpieces, the tips should be in one of the following:

a test chamber filled with irrigating solution,
a container of irrigating solution, or
the patient’s eye.

Vitrectomy

Failure to properly attach the tubing to the appropriate vacuum source or pressure source affects the vitrectomy handpiece operation. Be sure to read the handpiece package insert for correct assembly procedures and connection procedures.

Diathermy

When you select the Diathermy mode, you hear a tone or a voice. Also, you hear an audible tone when you apply diathermy power. You must check the diathermy cable periodically for damage. If the cable shows signs of damage, replace the cable immediately with the same type of cable. Use of other types of cables can affect the diathermy performance. During surgery, the diathermy output power should be as low as possible for the intended purpose. Johnson & Johnson Surgical Vision, Inc. recommends 30% setting to start. The patient should not come into contact with ungrounded metal parts when using diathermy. Position the diathermy cable in such a way that the cable avoids contact with the patient or other leads. For proper operation of the diathermy, replace the handpiece with the same type.

Power IV Pole

Do not exceed maximum weight of 25 pounds (11.25 Kg) on the IV pole bottle holder.

Foot Pedal

Never handle the foot pedal by its power cord.

Do not place the foot pedal on a wet surface.

WARNINGS

All personnel should read and understand the instructions in the COMPACT INTUITIV™ System operator’s manual before they use the system. Failure to do so may result in the improper operation of the system. Only a trained and licensed physician is to use this device. The system comes equipped with a 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin. The surgical staff must monitor the irrigation solution bottle height and the fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating. Low bottle height or low or empty bottle fluid level can result in: inadvertent chamber shallowing or collapse, aspiration or abrasion of the iris or other eye tissue, an ultrasonic wound heating commonly called wound burn (extreme case). DO NOT attempt to use the system if it fails to perform properly as stated in this manual. DO NOT use the system in the presence of any of the following as a fire can result: flammable anesthetics, other flammable gases, flammable fluids, flammable objects, oxidizing agents. Make sure that the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. JJSV recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the Single-Use Pack, Mayo stand cover, and monitor cover. Follow good operating room procedures to prevent injury or contamination. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. Make sure that you unlock the wheels before you move the cart. Make sure that the wheels move freely when moving the cart. Place monitoring electrodes or other types of equipment as far from those of the COMPACT INTUITIV™ System as possible. Johnson & Johnson Surgical Vision, Inc. recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient. The output power selected should be as low as possible for the intended purpose. This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note: The diathermy output is bipolar. Note: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis. Risk of burns and fire. Do not use near conductive materials such as metal bed parts, inner spring mattresses, and the like. Renew electrode cables on evidence of deterioration. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect the power before you service the equipment. Remove the power cord from the power outlet when the equipment is not in use. Do not obstruct the power outlet so you can readily remove the power cord. Not recommended for use in condensing environment. If exposed to condensing environment, allow system to equilibrate to typical operating room conditions prior to use. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. Do not use non-JJSV approved products with the COMPACT INTUITIV™ System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery.

Foot Pedals

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV™ SYSTEM

Rx Only

INDICATIONS

The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV™ System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

READ THE FOLLOWING SAFETY PRECAUTIONS AND WARNINGS CAREFULLY BEFORE YOU USE THE SYSTEM IN SURGERY

Do not use extension cords with your machine.
Do not overload your AC electrical outlet.
If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call Johnson & Johnson Surgical Vision, Inc. customer service to order a new cord.
Do not block the openings as heat build-up can cause system failures that can result in a fire hazard. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation.
Do not block the air fans on the bottom of the console as heat build-up can cause system failures which can result in a fire hazard.
Do not try to roll the system cart on carpets or over objects on the floor such as cables and power cords.
Take care not to trip over the power cords and the foot pedal cords.
Do not place the instrument on uneven or sloped surfaces.
Only use disposables, accessories, or other surgical instruments designed for this system. Use only parts recommended by Johnson & Johnson Surgical Vision, Inc. to achieve the optimum performance and the safety of the system.
Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup.
Do not exceed maximum weight of 25 pounds (11.25 Kg) on the Programmable IV Pole bottle holder.
Do not use more than one IV pole extender with the IV pole.
If there is no IV pole attached to the system, hang the irrigation fluid container at least 77 cm from the patient’s eye.
To protect the patient from contaminated fluids or handpieces, use only:

sterile tubing sets
sterile irrigation fluid
sterile handpieces

Use caution when handling handpiece with sharp edges or pointed tips.
Wrap the excess power cord neatly around the cord wrap on the back of the IV pole or cart.
Always replace the Single-Use Pack and irrigation solution bottle between surgical cases.

Changing Irrigation

Use extreme caution when you lower or raise the irrigation solution bottle to decrease fluid flow or increase fluid flow, and fluid pressure. If you lower the bottle too much it can cause the anterior chamber to collapse or to become too shallow; take care to avoid abrasion of tissues during phacoemulsification. If you raise the bottle too high it can cause the anterior chamber to deepen. Note: Use a new bottle of irrigation solution at the start of each case. Phacoemulsification Without Adequate Irrigation Operating phacoemulsification without an adequate irrigation flow can result in an elevated temperature of the tip and subsequent damage to the eye tissue or could cause the chamber to collapse. Confirm that there is irrigation flow before you initiate phacoemulsification. A tight wound or the angle of the needle next to the wound can also constrict the irrigation flow. Pinching of the coaxial irrigation sleeve assembly on the needle of the phaco handpiece causes the constriction.

Power Failure During Surgery

If there is a loss of power during a procedure, you need to:

Withdraw the handpiece from the eye; and
Release the foot pedal to position 0.

When power is restored:

Select Prime/Tune to reprime the fluids and tune the phaco handpiece. Use Bypass to reduce the length of prime time.
Select the mode that was in use when the system lost power (Phaco, IA, Vitrectomy, or Diathermy).

Connecting Handpieces

It is very important that the electrical connectors on the handpieces are completely dry prior to connecting them to the system receptacles. You may receive a “Phaco Handpiece Error” message if the connector is wet.

Handling the Phaco Handpiece

The phaco handpiece is a very delicate instrument and you must handle the handpiece with EXTREME care. If you drop the handpiece or the handpiece receives any other significant impact, the handpiece might not work properly. The ultrasonic titanium phaco tip must never touch any solid material while in use. Always clear the handpiece of fluid immediately following surgery. See cleaning instructions in Chapter 7 "Care and Cleaning". Handpieces can be extremely hot immediately after sterilization. Use care and caution when handling.

Phaco and Vitrectomy Operation

Do not activate the Phaco and Vitrectomy handpieces with the tips in air as this reduces the useful life of the handpiece and the cutter. When introducing power to the Phaco or Vitrectomy handpieces, the tips should be in one of the following:

a test chamber filled with irrigating solution,
a container of irrigating solution, or
the patient’s eye.

Vitrectomy

Failure to properly attach the tubing to the appropriate vacuum source or pressure source affects the vitrectomy handpiece operation. Be sure to read the handpiece package insert for correct assembly procedures and connection procedures.

Diathermy

When you select the Diathermy mode, you hear a tone or a voice. Also, you hear an audible tone when you apply diathermy power. You must check the diathermy cable periodically for damage. If the cable shows signs of damage, replace the cable immediately with the same type of cable. Use of other types of cables can affect the diathermy performance. During surgery, the diathermy output power should be as low as possible for the intended purpose. Johnson & Johnson Surgical Vision, Inc. recommends 30% setting to start. The patient should not come into contact with ungrounded metal parts when using diathermy. Position the diathermy cable in such a way that the cable avoids contact with the patient or other leads. For proper operation of the diathermy, replace the handpiece with the same type.

Power IV Pole

Do not exceed maximum weight of 25 pounds (11.25 Kg) on the IV pole bottle holder.

Foot Pedal

Never handle the foot pedal by its power cord.

Do not place the foot pedal on a wet surface.

WARNINGS

All personnel should read and understand the instructions in the COMPACT INTUITIV™ System operator’s manual before they use the system. Failure to do so may result in the improper operation of the system. Only a trained and licensed physician is to use this device. The system comes equipped with a 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin. The surgical staff must monitor the irrigation solution bottle height and the fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating. Low bottle height or low or empty bottle fluid level can result in: inadvertent chamber shallowing or collapse, aspiration or abrasion of the iris or other eye tissue, an ultrasonic wound heating commonly called wound burn (extreme case). DO NOT attempt to use the system if it fails to perform properly as stated in this manual. DO NOT use the system in the presence of any of the following as a fire can result: flammable anesthetics, other flammable gases, flammable fluids, flammable objects, oxidizing agents. Make sure that the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. JJSV recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the Single-Use Pack, Mayo stand cover, and monitor cover. Follow good operating room procedures to prevent injury or contamination. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. Make sure that you unlock the wheels before you move the cart. Make sure that the wheels move freely when moving the cart. Place monitoring electrodes or other types of equipment as far from those of the COMPACT INTUITIV™ System as possible. Johnson & Johnson Surgical Vision, Inc. recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient. The output power selected should be as low as possible for the intended purpose. This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note: The diathermy output is bipolar. Note: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis. Risk of burns and fire. Do not use near conductive materials such as metal bed parts, inner spring mattresses, and the like. Renew electrode cables on evidence of deterioration. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect the power before you service the equipment. Remove the power cord from the power outlet when the equipment is not in use. Do not obstruct the power outlet so you can readily remove the power cord. Not recommended for use in condensing environment. If exposed to condensing environment, allow system to equilibrate to typical operating room conditions prior to use. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. Do not use non-JJSV approved products with the COMPACT INTUITIV™ System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery.

 

IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE™ PHACOEMULSIFICATION SYSTEM

Rx Only

INDICATIONS

The Johnson & Johnson Surgical Vision, Inc. WHITESTAR Signature™ Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

SAFETY PRECAUTIONS

Read the following Safety Precautions and Warnings carefully before you use the WHITESTAR Signature™ System in surgery. Risks and complications may include broken ocular capsule or corneal burn. The system comes equipped with 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin. If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call JJSV customer service to order a new cord. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation. Do not block the openings; as heat build-up can cause system failures which can result in a fire hazard. Do not try to move the system cart on deep pile carpets or over objects on the floor such as cables and power cords. Take care not to trip over power and foot pedal cords. Do not try to lift the system console. Do not place the instrument on uneven or sloped surfaces. Only use disposables, accessories, or other surgical instruments designed for this system. For optimum performance of the system and safety, use only parts recommended by JJSV. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup. To protect the patient from contaminated fluids or handpieces, use only sterile tubing packs, sterile irrigation fluid, and sterile handpieces. Wrap the excess power cord neatly around the cord wrap on the back of the console. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. Use caution when you use handpieces with sharp edges or pointed tips. Always replace the tubing pack between cases.

WARNINGS

Read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained licensed physician can use this device. The surgical staff must monitor the balanced salt solution bottle height and fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating. Low bottle height or low or empty bottle fluid level can result in: Inadvertent chamber shallowing or collapse, Aspiration or abrasion of the iris or other tissue, An ultrasonic wound heating commonly called wound burn (extreme case). DO NOT attempt to use the system if the system fails to perform properly as stated in this manual. DO NOT use the system in the presence of any of the following as a fire can result: flammable anesthetics, other flammable gases, flammable fluids, flammable objects, and oxidizing agents. Make sure that the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. JJSV recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the tubing pack, mayo stand drape, and monitor drape. Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR Signature™ System as possible. JJSV recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). The output power selected must be as low as possible for the intended purpose. This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note: The diathermy output is bipolar. Note: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis. Risk of burns and fire. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect the power before you service the equipment. Remove the power cord from the power outlet when the equipment is not in use. Do not obstruct the power outlet so you can readily remove the power cord. Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. DO NOT try to replace the wireless remote control batteries. Call your JJSV technical service representative to replace the batteries. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. Do not use non-JJSV approved products with the WHITESTAR Signature™ System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery. VITRECTOMY: CAUTION: Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. PHACO HANDPIECE SETUP CAUTION: Never attempt to straighten a bent needle. This might produce a broken tip when you apply ultrasound. CAUTION: Do not sterilize the handpieces prior to performing the cleaning procedures described in the Owner’s Manual. CAUTION: Do not clean the phaco handpiece with any type of ultrasonic cleaning device; the cleaning device can damage the piezoelectric crystals. WARNING: Improper/inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation of particles into the surgical field. In addition, the function and life expectancy of the phaco handpiece can become compromised. WARNING: Handle the phaco handpiece with extreme care. The piezoelectric crystal in the handpiece is very sensitive to shock. If the handpiece is dropped, it is possible that the handpiece might not function correctly. If this happens, contact JJSV for repair information or replacement handpiece. WARNING: Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. Use a backup handpiece for surgery if there are any questionable characteristics of the handpiece. Use of contaminated or damaged system accessories can cause patient injury. WARNING: The handpiece can deteriorate with the use of balanced salt solutions. Balanced salt solution tarnishes and pits metal. Proper cleaning of the instruments prolongs their useful life. JJSV recommends using sterile non-pyrogenic water to clean the handpieces and accessories. STERILIZATION: CAUTION: JJSV does not recommend gas sterilization. CAUTION: Do not sterilize the handpieces prior to performing the cleaning procedures described in the Owner’s Manual. Do not place the storage cases provided in an autoclave. WARNING: Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. In addition, JJSV recommends a terminal sterilization cycle in the autoclave after the final case of the day. This cycle must include a drying cycle to remove moisture from the tubing and handpieces for storage. WARNING: Handle the phaco handpiece with extreme care. The piezoelectric crystal in the handpiece is very sensitive to shock. If you drop the handpiece, it is possible that the handpiece might not function correctly. If this happens, contact JJSV for repair information for the handpiece or a replacement handpiece. DIATHERMY: CAUTION: If you do not hear a tone when you press the foot pedal and volume adjustment is unsuccessful, the mode is not functioning properly. PRIME/TUNE: WARNING: If you do not properly prime the IA tubing, errors can occur. CAUTION: Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. REMOTE CONTROL WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your JJSV Technical Service representative to replace the batteries.

 

Phacoemulsification Handpieces

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE ELLIPS™ FX PHACO HANDPIECE AND WHITESTAR™ PHACO HANDPIECE

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INDICATIONS

The WHITESTAR™ Phaco Handpiece is utilized during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments.

INDICATIONS

The ELLIPS™ FX Phaco Handpiece is utilized during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments.

CAUTIONS

Never attempt to straighten a bent needle. This will products a broken tip when phaco power is applied. Do not clean the phaco handpiece with any type of ultrasonic cleaning device; it will damage the piezoelectric crystals. Do not use tap water for cleaning. Do not sterilize the handpiece prior to performing the cleaning procedure described in the directions for use.

PRECAUTIONS

Only use this ELLIPS™ FX Phaco Handpiece and WHITESTAR™ Phaco Handpiece with the WHITESTAR Signature™ or SOVEREIGN™ Compact version 5.2 or higher phacoemulsification machines. Overall system performance may be impaired when used in combination with non-Johnson & Johnson Surgical Vision, Inc. products. It is important that the electrical connector on the handpiece is completely dry prior to connecting it to the WHITESTAR Signature™ or SOVEREIGN™ Compact phacoemulsification machine receptacles. Moisture will prevent the handpiece from operating properly and you may receive a handpiece error message on the panel display of the phacoemulsification machine if the connector is wet.

WARNINGS

Improper/inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation of particles into the surgical field. In addition, the function and life expectancy of the phaco handpiece may become compromised. The use of gas sterilization is not recommended. The surgical staff must monitor the balanced salt solution height and fluid level at all times. A low bottle/bag height or empty bottle/bag affects the fluid balance and the intraocular pressure (IOP) while aspirating and can result in: Inadvertent chamber shallowing or collapse, aspiration or abrasion of iris or other eye tissue, an ultrasonic wound heating commonly called wound burn (extreme case)

ATTENTION

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

Phacoemulsification Packs

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE FUSION™ DUAL PUMP PACK (OPO73)

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INDICATIONS

The DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR Signature™ or WHITESTAR SIGNATURE™ PRO Systems (“WHITESTAR Signature™  System(s)”). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

WARNING

Single use only. Do not re-sterilize, reprocess, or reuse this device.

PRECAUTIONS

Do not use product after its expiration date marked on product’s packaging labels. Contents are sterile when product tray is sealed with lid and undamaged. Do not resterilize and do not reuse. Only use this DUAL PUMP Pack with the WHITESTAR Signature™ Systems. Overall system performance may be impaired when used in combination with non-Johnson & Johnson Surgical Vision, Inc. products. If product performance becomes compromised during use, discontinue use and perform the appropriate tests as detailed in the Operator’s Manual. If results are not satisfactory, replace the DUAL PUMP Pack according to instructions defined in the Operator’s Manual.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR MULTIPLE-USE PACK (OPO85)

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INDICATIONS

The OPO85 is used with the COMPACT INTUITIV™ System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

CAUTION

Do not sterilize the OPO85 prior to performing the cleaning procedure described in OPO85 Directions for Use.

WARNINGS

Sterility assurance is the responsibility of the user. The use of gas resterilization is not recommended. If the OPO85 is received in an unsatisfactory condition, please contact your local Johnson & Johnson Surgical Vision, Inc. Sales Office immediately. Each OPO85 is identified by a lot number and this should be included in any correspondence or discussions.

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Only use the OPO85 with the COMPACT INTUITIV™ System. Overall system performance may be impaired when used in combination with non-JJSV products. If product performance becomes compromised during use; discontinue use and perform the appropriate steps as detailed in the Operator’s Manual. If results are not satisfactory, replace the OPO85 according to instructions defined in the Operator’s Manual. Improper/inadequate cleaning may result in particulate matter adhering to the internal surfaces of the tubing and MANIFOLD. As a result, the functionality of OPO85 may become compromised. After a maximum of 20 uses (19 reuses), the OPO85 must be discarded. The OPO85 has not been tested past 20 uses. Always ensure proper COMPACT INTUITIV™ System settings are used with the OPO85. Only use approved OPO85 accessories.

 

WHITESTAR SIGNATURE™ PRO Phacoemulsification System

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE™ PRO SYSTEM

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INDICATIONS

The WHITESTAR SIGNATURE™ PRO SYSTEM is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. The modular design allows the users to configure the system to meet their surgical requirements.

WARNINGS

All personnel who might operate this equipment must read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained, licensed physician can use this device. Do not modify the WHITESTAR SIGNATURE™ PRO SYSTEM. The system comes equipped with a 3-prong power plug, which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin. DO NOT attempt to use the system if the system fails to perform properly as stated in this manual. DO NOT use the system in the presence of any of the following as a fire can result: flammable anesthetics, other flammable gases, flammable fluids, flammable objects and oxidizing agents. Make sure the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. Johnson & Johnson Surgical Vision, Inc. recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the fluidics pack, Mayo tray drape, and monitor drape. Make sure that the fluidics pack drain bag does not over-fill. The maximum capacity of the bag is 750 cc. Use caution when you extend, retract, or swivel the Mayo tray articulating arm. Stay clear of the hinged hardware. Do not modify the pole height or manually force the pole height because this could cause incorrect indication of bottle height and patient injury. Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR SIGNATURE™ PRO SYSTEM as possible. JJSV recommends high current limiting devices for the protection of such systems. Do not use needle-monitoring electrodes. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient. The output power selected must be as low as possible for the intended purpose. This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note: The diathermy output is bipolar. Note: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis. Risk of burns and fire. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect the power before you service the equipment. Remove the power cord from the power outlet when the equipment is not in use. Do not obstruct the power outlet so you can readily remove the power cord. Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. DO NOT try to replace the batteries for the wireless remote control, the Advanced Control Pedal. Call your JJSV technical service representative to replace the batteries. DO NOT try to replace the wireless remote control batteries. Call your JJSV technical service representative to replace the batteries. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. Do not have the handpiece tip in the eye of the patient when you prime and tune the handpiece. Do not use non-JJSV approved products with the WHITESTAR SIGNATURE™ PRO SYSTEM, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the WHITESTAR SIGNATURE™ PRO SYSTEM or shielding the location. WHITESTAR SIGNATURE™ PRO SYSTEM needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF communications equipment can affect WHITESTAR SIGNATUR™ PRO SYSTEM. The use of accessories, transducers and cables other than those specified by JJSV, may result in increased EMISSIONS or decreased IMMUNITY of the WHITESTAR SIGNATURE™ PRO. The WHITESTAR SIGNATURE™ PRO SYSTEM should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the WHITESTAR SIGNATURE™ PRO SYSTEM should be observed to verify normal operation in the configuration in which it will be used. Do not replace the Advanced Linear Pedal (ALP) battery when the pedal is attached to a power source. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the WHITESTAR SIGNATURE™ PRO SYSTEM or shielding the location. WHITESTAR SIGNATURE™ PRO SYSTEM may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. If you do not properly prime the I/A tubing, errors can occur.

SAFETY PRECAUTIONS

Read the following safety precautions and warnings carefully before you use the system in surgery. Do not use extension cords with your system. Do not overload your electrical receptacle (outlet). If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call JJSV customer service to order a new cord. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation. Do not block the openings; as heat build-up can cause system failures, which can result in a fire hazard. Do not try to move the system cart on deep pile carpets or over objects on the floor such as cables and power cords. Take care not to trip over power and foot pedal cords. Do not try to lift the system console. Do not place the instrument on uneven or sloped surfaces. Only use disposables, accessories, or other surgical instruments designed for this system. For optimum performance of the system and safety, use only parts recommended by JJSV. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup. To protect the patient from contaminated fluids or handpieces, use only sterile tubing packs, sterile irrigation fluid, and sterile handpieces. Wrap the excess power cord neatly around the cord wrap on the back of the console. Use caution when you use handpieces with sharp edges or pointed tips. Always replace the tubing pack and the balanced salt solution bottle between cases.

CAUTIONS

Never attempt to straighten a bent needle. This might produce a broken tip when you apply ultrasound. Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. If you do not hear a tone when you press the foot pedal and volume adjustment is unsuccessful, the mode is not functioning properly.

WARNINGS FOR CASA

System passwords are set only by JJSV Service personnel. Be sure to keep system passwords in a secure location. The connection to a WHITESTAR SIGNATURE™ PRO SYSTEM only provides a means to retrieve files from the System, and does not provide the means to send files back to the System. The CASA application will display a notification when the total storage capacity of the iPad device is less than 2 GB. It is important to note there is no patient data on the WHITESTAR SIGNATURE™ PRO SYSTEM, and no patient data is imported to the CASA application. Care must be taken when removing data from the iPad device. If the data is removed without having exported it in an email, there will be no way to import the data back into the iPad device.

ATTENTION

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

 

iDESIGN™ Refractive Studio

INDICATIONS AND IMPORTANT SAFETY INFORMATION STAR S4 IR™ LASER, THE iDESIGN™ REFRACTIVE STUDIO AND THE iDESIGN™ ADVANCED WAVESCAN STUDIO SYSTEM

Indications for Use

The STAR S4 IR™ Excimer Laser System and the iDESIGN™ Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision, with myopic astigmatism, up to -6.00 D spherical equivalent as measured by iDESIGN™ Refractive Studio, with cylinder up to -3.00 D, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN™ Refractive Studio refraction as follows: Spherical equivalent: Magnitude of the difference is less than 0.625 D, Cylinder: Magnitude of the difference is less than or equal to 0.50 D, Cylinder Axis: If either the manifest cylinder, entered into the iDESIGN™ Refractive Studio, or the iDESIGN™ Refractive Studio cylinder selected for treatment is less than 0.50 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.50 D, the axis tolerance is linearly reduced from 15° (0.5 D) to 7.5° (7.0 D or greater) based on the average magnitude of both cylinders. With documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and with a successful preoperative trial of monovision or history of monovision experience. The STAR S4 IR™ Excimer Laser System and iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: With hyperopia with and without astigmatism as measured by iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio up to +4.00 D spherical equivalent, with up to 2.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D; 18 years of age or older, and with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). The STAR S4 IR™ Excimer Laser System and iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with mixed astigmatism as measured by iDESIGN™ Advanced WaveScan Studio System /iDESIGN™ Refractive Studio where the magnitude of cylinder (1.0 D to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 18 years of age or older, and with refractive stability (a change of <1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). The STAR S4 IR™ Excimer Laser System and iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with myopia as measured by iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio up to -11.00 D spherical equivalent, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN™ Advanced WaveScan Studio System/iDESIGN™ Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D. Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 18 years of age or older, and with refractive stability (a change of <1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System.The STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism from -6.00 to -11.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism up to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.50D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of hyperopia and hyperopic astigmatism up to 3.00 D MRSE, with cylinder between 0.00 and 2.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination.

Conventional LASIK procedure using the STAR S4 IR™ Excimer Laser System

Laser assisted in situ keratomileusis (LASIK) procedure using the STAR S4 IR™ Excimer Laser System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -14.0 D with or without refractive astigmatism from 0.5 to 5.0D*; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with or without refractive astigmatism up to +3.0 D, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. In patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (£6.0 D at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs.

Conventional PRK procedure using the STAR S4 IR™ Excimer Laser System

Photorefractive Keratectomy (PRK) procedure using the STAR S4 IR™ Excimer Laser System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -6.0 D spherical equivalent at the corneal plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -12.0 D spherical myopia at the spectacle plane with no more than 4.0 D of refractive astigmatism¹; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +1.0 and +6.0 D sphere at the spectacle plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with refractive astigmatism from +0.5 to +4.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D.

Contraindications

Laser refractive surgery is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients with corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea; in patients with symptoms of significant dry eyes. If the patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma; in patients with advanced glaucoma; in patients with uncontrolled diabetes; in patients with documented evidence of a change in manifest refraction of more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. in patients taking medications with ocular side effects. Examples are Isotretinoin (Accutane^®) for acne treatment or Amiodarone hydrochloride (Cordarone^®) for normalizing heart rhythm.

Warnings

LASIK is not recommended in patients who have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status; have a history of Herpes simplex or Herpes zoster keratitis; have severe allergies or tendency rub their eyes often; have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect); are taking the medication Isotretinoin (Accutane);are taking antimetabolites for any medical conditions.

Precautions:

To reduce the risk of corneal ectasia, the posterior 250 microns (µm) of corneal stroma should not be violated. Please refer to Operator’s Manual for a list of additional Precautions

Adverse Events:

Prior clinical study of monovision LASIK using the WaveScan Wavefront^® System aberrometer, supports the safety and effectiveness of iDESIGN™ driven Monovision LASIK Treatment. Please refer to Operator’s Manual for a list of Adverse Events and complications in clinical studies for Monovision in Presbyopic Patients with Low to Moderate Myopia and Myopic Astigmatism, Myopia, Mixed Astigmatism and Hyperopia.

LASIK label
Rx Only

¹ Caution must be used to calculate treatment in MINUS CYLINDER at the spectacle plane (vertex distance 12.5 mm) before entering the refraction into the laser in order to conform with the Indications for Use.

iFS™ Advanced Femtosecond Laser

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE iFS™ ADVANCED FEMTOSECOND LASER

INDICATIONS

The iFS™ femtosecond laser is an ophthalmic surgical laser indicated for use in patients undergoing surgery or treatment requiring initial lamellar resection of the cornea, in treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, in treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal, In lamellar IEK and corneal harvesting; in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the corneal, in the creation of a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK, in treatment requiring the creation of corneal channels for placement/insertion of a corneal inlay device. 

CONTRAINDICATIONS

Lamellar resection for the creation of a corneal flap is contraindicated in the presence of corneal edema, corneal lesions, hypotony, glaucoma, existing corneal implant, or keratoconus.  IEK procedures and arcuate incisions are contraindicated in the presence of any corneal opacity adequately dense to obscure visualization of the iris, descemetocele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, or corneal thickness requirements that are beyond the range of the system. Creation of corneal channels for placement/insertion of a corneal inlay device are contraindicated in the presence of any corneal opacity adequately dense to obscure visualization of the iris, descemetocele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, corneal thickness requirements that are beyond the range of the system, any previous incisional refractive corneal procedure, e.g. radial keratotomy, significant corneal neovascularization in the limbal area for a planned incision, previous history of corneal Herpes Simplex Keratitis, previous corneal transplant, any cataract, corneal edema, corneal lesions, hypotony, existing corneal implant, keratoconus or subjects with severe corneal thinning less than 450 microns.

PRECAUTIONS

A high level of surgical skill is required for these lasers. A surgeon should have successfully completed one or more training courses before attempting to create a corneal resection. The use of the iFS™ Laser for IEK procedures or for arcuate incisions is not recommended for patients with severe corneal thinning, preexisting glaucoma, a history of steroid-responsive rise in intraocular pressure, preoperative intraocular pressure greater than 21 mm Hg in the operative eye, more than 1200 mm corneal thickness at the 9 mm peripheral zone, active intraocular inflammation, or active ocular infection or keratoconus. The use of the iFS™ laser for creation of corneal channels for placement of a corneal inlay device is not recommended for patients with preexisting glaucoma, a history of steroid-responsive rise in intraocular pressure, preoperative intraocular pressure greater than 21 mm Hg in the operative eye, more than 1200 mm corneal thickness at the 9 mm peripheral zone, active intraocular inflammation, or active ocular infection or keratoconus.

ADVERSE EVENTS

Possible complications resulting from LASIK flap creation include corneal edema/inflammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia, flap decentration, incomplete flap creation, flap tearing or incomplete lift-off, free cap, inflammation (e.g., diffuse lamellar keratitis, corneal infiltrates, or iritis), thin or thick flaps, or flap striae.  Transient light sensitivity syndrome (TLSS) and peripheral light spectrum (PLS) have been sporadically reported and may occur following LASIK flap creation. TLSS is characterized by symptoms of mild to severe light sensitivity that manifests between 2 and 6 weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity is observed in approximately 1% of patients who undergo flap creation with either laser. Patients respond to the use of hourly topical steroids and most report improvement within 1 week of treatment. PLS is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however, the potential diffractive effects may be bothersome to some patients. Reported in only 0.03% of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within 3 months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.  Arcuate incision complications include corneal edema/inflammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia or corneal endothelium perforation.  Creation of corneal channel for placement of a corneal inlay device complications include corneal edema, corneal pain, epithelial ingrowth, epithelial defect, infection, implant de-centration, incomplete inlay channel creation, corneal tearing or incomplete inlay channel dissection, photophobia, corneal inflammation, such as diffuse lamellar keratisis (DLK), corneal infiltrates, and iritis, and inlay channel bleeding.

WARNINGS

Check all treatment parameters for accuracy. The posterior depth should be programmed at least 125 microns above the corneal endothelium. Use of these laser systems allows laser surgical incisions up to 1200 µm deep. Setting the posterior depth too deep could result in injury to other ocular structures. Use caution when setting cut position and cut angle to avoid overlapping arcuate incisions. The applanation lens becomes etched by the laser during the side-cut procedures and must not be reused. Laser light will not effectively permeate an etched lens, and the precision of the laser will be altered. Patient interface disposables should not be reused or resterilized.

CAUTION

U.S. Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner who has been trained in the calibration and operation of this device.

 

STAR S4 IR™ Excimer Laser

INDICATIONS AND IMPORTANT SAFETY INFORMATION STAR S4 IR™ LASER AND iDESIGN™ ADVANCED WAVESCAN STUDIO SYSTEM

CAUTION

U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.

ATTENTION

Reference the Operator’s Manual for a complete listing of Indications and Important Safety Information.

INDICATIONS

The STAR S4 IR™ Excimer Laser and the iDESIGN™ System is indicated for wavefront‑guided LASIK in patients with myopia as measured by the iDESIGN™ System up to  -11.00 D SE, with up to -5.00 D cylinder; in patients with hyperopia with or without astigmatism as measured by the iDESIGN™ System up to +4.00 D SE, with up to +2.00 D cylinder; and in patients with mixed astigmatism as measured by the iDESIGN™ System where the magnitude of the cylinder (1.0 D to 5.0 D) is greater than the magnitude of the sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and the iDESIGN™ System refraction of 1) SE: magnitude of the difference is ˂ 0.625 D, and 2) cylinder: magnitude of the difference is ≤ 0.5 D; with patients 18 years of age and older, and with refractive stability (a change of ≤ 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).  

CONTRAINDICATIONS

Laser refractive surgery is contraindicated for:  patients with collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, patients with signs of corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, patients with symptoms of significant dry eyes, patients whose corneal thickness would cause the anticipated treatment to violate the posterior 250 microns (μm) of corneal stroma, and in patients with advanced glaucoma, and uncontrolled diabetes. If the patients have severely dry eyes, LASIK may increase the dryness; this may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery; it may result in poor vision after LASIK.   

WARNINGS AND PRECAUTIONS

LASIK is not recommended in patients who: have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status, have a history of Herpes simplex or Herpes zoster keratitis, have severe allergies or tendency rub their eyes often, have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect), are taking the medication Isotretinoin (Accutane^®), are taking antimetabolites for any medical conditions. The safety and effectiveness of this laser for LASIK correction have NOT been established in patients:  with progressive refractive errors, ocular disease, corneal abnormality, previous corneal or intraocular surgery, or trauma in the ablation zone, who are taking the medication Sumatriptan (Imitrex^®), or Amiodarone hydrochloride (Cordarone^®), with corneal neovascularization within 1.0 mm of the ablation zone, over the long term (more than 1 year after surgery for myopia and more than 2 years for mixed astigmatism), for patients who engage in activities that could endanger or damage the LASIK flap, for patients who have a family history of degenerative corneal disease, history of inflammation of the eye, for patients who have a history of crossed eyes (strabismus) or who have undergone strabismus surgery, prior LASIK or Refractive Surgery, with history of any eye diseases or abnormalities such as corneal scars or active disease, and whose BSCVA is worse than 20/20. To reduce the risk of corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated. The treatment of highly myopic eyes necessitates the removal of significant amounts of corneal tissue.  The iDESIGN™ System calculates the estimated residual bed depth using the pachymetry and intended flap thickness entered by the user. Actual flap thicknesses may vary. If the estimated residual stromal bed is ≤ 320 microns, an in-the-bed pachymetric measurement should be performed. 

ADVERSE EVENTS

Possible adverse events include loss of best spectacle corrected visual acuity (BSCVA), serious Transient Light Sensitivity Syndrome, serious primary open angle glaucoma, miscreated flap, melting of the flap, severe glare, and severe dry eyes. Complications can include corneal edema, epithelial ingrowth, diffuse lamellar keratitis, foreign body sensation, and pain.

TECNIS^® Multifocal IOL +4.0D

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® MULTIFOCAL FAMILY OF 1-PIECE IOLs

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INDICATIONS

TECNIS^® Multifocal Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

WARNINGS

Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos or glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions. On rare occasions these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared to a monofocal lens. Therefore, subjects with multifocal lenses should exercise caution when driving at night or in poor visibility conditions. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient's eyesight: patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat posterior segment diseases, surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss), a distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, circumstance that would result in damage to the endothelium during implantation, suspected microbial infection, patients in whom neither the posterior capsule nor zonules are intact enough to provide support, congenital bilateral cataracts, recurrent severe anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye, previous history of, or a predisposition to, retinal detachment, patients with only one eye with potentially good vision, medically uncontrollable glaucoma, corneal endothelial dystrophy, and proliferative diabetic retinopathy. The TECNIS^® Multifocal 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. The splitting of the light into more than one focus may affect image quality and lead to some reduction of contrast sensitivity. Well-informed patients with well-defined visual needs and preferences should be selected for TECNIS^® Multifocal 1-Piece lens implantation. The patients should be informed about the possibility that a decrease in contrast sensitivity and an increase of visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions. Patients with a predicted postoperative astigmatism > 1.0 diopter may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Care should be taken to achieve IOL centration, as lens decentration may result in patients experiencing visual disturbances, particularly in patients with large pupils under mesopic conditions.

PRECAUTIONS

Prior to surgery the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. There were no patients 21 years old or younger included in the clinical studies; therefore there are insufficient clinical data to demonstrate safety and effectiveness in this age group. The central one millimeter area of the TECNIS^® Multifocal 1-Piece IOL creates a far image focus in accordance with the labeled power of the IOL, so patients with abnormally small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however because this multifocal design has not been tested in patients with abnormally small pupils it is unclear whether such patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of patients with multifocal lenses. Manual refraction is strongly recommended. Recent contact lens usage may affect the patient’s refraction; therefore in contact lens wearers surgeons should establish corneal stability without contact lenses prior to determining IOL power. When performing wavefront measurements on a patient with a multifocal lens, two different wavefronts are produced. One wavefront will be in focus (either far or near) and the other wavefront will be out of focus. In this situation, incorrect interpretation of the wavefront measurement is possible. The long term effects of intraocular lens implantation have not been determined. Therefore the physician should continue to monitor implant patients postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize this intraocular lens by any method. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature > 45°C (113°F). Do not autoclave the intraocular lens. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration of the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the TECNIS^®Multifocal 1-Piece Intraocular lens may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system.

ADVERSE EVENTS

The most frequently reported cumulative adverse event for first eyes during the clinical trial was secondary surgical re-intervention 3.7% with 0.6% being lens-related. The total number of first eyes with lens-related events during and after the study was 0.9%. Other reported adverse events for first eyes were macular edema (2.6%), hypopyon (0.3%) and endophthalmitis (0.3%).

 

TECNIS^® Multifocal IOL +2.75D, TECNIS^® Multifocal IOL +3.25D

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® MULTIFOCAL FAMILY OF 1-PIECE IOLs

Rx Only

INDICATIONS

The TECNIS^® Multifocal 1-Piece Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the conditions described in the Directions for Use should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions. On rare occasions, these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Contrast sensitivity is reduced with a multifocal lens compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Care should be taken to achieve centration, as lens decentration may result in patients experiencing visual disturbances, particularly in patients with large pupils under mesopic conditions. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. Patients with certain medical conditions may not be suitable candidates for IOLs. Consult the Directions for Use for more information.

PRECAUTIONS

Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to patient. There were no patients 21 years old or younger included in the clinical studies; therefore there are insufficient clinical data to demonstrate safety and effectiveness in this age group. The central one millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils (~1mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The long-term effects of intraocular lens implantation have not been determined; therefore implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or over 45°C (113°). Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system.

ADVERSE EVENTS

The most frequently reported adverse event that occurred during the clinical trials of the TECNIS^® Multifocal lenses was surgical re-intervention, most of which were non-lens-related. Lens-related re-interventions occurred at a rate of 0.6% to 1.0%. Other surgical re-interventions included lens exchanges (for incorrect IOL power), retinal repair, ruptured globe repair, macular hole repair, removal of retained lens material, treatment injections for cystoid macular edema and iritis, and blepharoplasty.

 

TECNIS Symfony^® Toric IOL, TECNIS Symfony^® IOL

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS SYMFONY^® TORIC EXTENDED RANGE OF VISION IOLs

Rx Only

INDICATIONS

The TECNIS Symfony^® Extended Range of Vision IOL, model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model ZXR00 IOL is intended for capsular bag placement only. The TECNIS Symfony^® Toric Extended Range of Vision IOLs, models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model series ZXT IOLs are intended for capsular bag placement only.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition, or may pose an unreasonable risk to the patient’s eyesight:  patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye, patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss), a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible, circumstances that would result in damage to the endothelium during implantation, suspected microbial infection, patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL, children under the age of 2 years are not suitable candidates for intraocular lenses, congenital bilateral cataracts, previous history of, or a predisposition to, retinal detachment, patients with only one good eye with potentially good vision, medically uncontrollable glaucoma, corneal endothelial dystrophy or proliferative diabetic retinopathy. The TECNIS Symfony^® IOL should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus. The TECNIS Symfony^® IOL may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL. The physician should carefully weigh the potential risks and benefits for each patient, and should fully inform the patient of the potential for reduced contrast sensitivity before implanting the lens in patients. Special consideration of potential visual problems should be made before implanting the lens in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease which may cause present or future reduction in acuity or contrast sensitivity. Because the TECNIS Symfony^® IOL may cause a reduction in contrast sensitivity compared to a monofocal IOL, patients implanted with the lens should be informed to exercise special caution when driving at night or in poor visibility conditions. Some visual effects associated with the TECNIS Symfony^® IOL may be expected due to the lens design that delivers elongation of focus. These may include a perception of halos, glare, or starbursts around lights under nighttime conditions. The experience of these phenomena will be bothersome or very bothersome in some people, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient may request removal of the IOL. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for implantation with the TECNIS Symfony^® and TECNIS Symfony^® Toric IOLs, models ZXR00, ZXT150, ZXT225, ZXT300, and ZXT375, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower astigmatism. The effectiveness of TECNIS Symfony^® Toric IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism less than 1.0 diopter has not been demonstrated. Rotation of TECNIS Symfony^® Toric IOLs away from their intended axis can reduce their astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. Johnson & Johnson Surgical Vision, Inc. IOLs are single-use devices only. Do not reuse this IOL.

PRECAUTIONS

Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. When performing refraction in patients implanted with the TECNIS Symfony^®IOL, interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is recommended. The ability to perform some eye treatments (e.g. retinal photocoagulation) may be affected by the TECNIS Symfony^® IOL optical design. Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power.  Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions. When the insertion system is used improperly, TECNIS Symfony^® IOLs may not be delivered properly (i.e., haptics may be broken). Please refer to the specific instructions for use provided with the insertion instrument or system. The safety and effectiveness of TECNIS Symfony^® IOLs have not been substantiated in patients with preexisting ocular conditions and intraoperative complications (see the following for examples). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions: [before surgery] pupil abnormalities, prior corneal refractive or intraocular surgery, choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism, amblyopia, macular disease, pregnancy, [during surgery] excessive vitreous loss, non-circular capsulotomy/capsulorhexis, the presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular capsulotomy/capsulorhexis cannot be confirmed by direct visualization, cataract extraction by techniques other than phacoemulsification or liquefaction, capsular rupture, significant anterior chamber hyphema, uncontrollable positive intraocular pressure, or zonular damage. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or overinflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS Symfony^®Toric IOL with the intended axis of placement. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS^® Toric intraocular lens labeling. Please refer to the TECNIS Toric Calculator user manual for more information. The use of methods other than the TECNIS Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the parent TECNIS^® Toric IOL U.S. IDE study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS Toric Calculator (www.TecnisToricCalc.com), are recommended to achieve optimal visual outcomes for the TECNIS Symfony^® Toric IOL. All preoperative surgical parameters are important when choosing a TECNIS Symfony^® Toric IOL for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes, and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the parent TECNIS^® Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study for the parent Tecnis Toric IOL. Note that the TECNIS Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Potential adverse effects (e.g., complications) associated with the use of the device include the following: infection (endophthalmitis), hypopyon, iol dislocation, cystoid macular edema, corneal edema, pupillary block, iritis, retinal detachment/tear, raised iop requiring treatment visual symptoms requiring lens removal, tilt and decentration requiring repositioning, and residual refractive error resulting in secondary intervention. Secondary surgical interventions include, but are not limited to: lens repositioning (due to decentration, rotation, subluxation, etc.), lens replacement, vitreous aspirations or iridectomy for pupillary block, wound leak repair, retinal detachment repair, corneal transplant, lens replacement due to refractive error, unacceptable optical/visual symptoms and severe inflammation. 

SERIOUS ADVERSE EVENTS

The most frequently reported serious adverse events that occurred during the clinical trial of the TECNIS Symfony^® Lens were cystoid macular edema (2 eyes, 0.7%) and surgical reintervention (treatment injections for cystoid macular edema and endophthalmitis, 2 eyes, 0.7%). One eye was reported with pupillary capture and the eye that had endophthalmitis also had a small hypopyon. No other serious adverse events and no lens-related adverse events occurred during the trial.

 

TECNIS^® Toric IOL

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® TORIC 1-PIECE IOL

Rx Only

INDICATIONS

The TECNIS^® Toric 1-Piece Posterior Chamber Lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS^® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These circumstances include recurrent severe anterior or posterior segment inflammation or uveitis; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The clinical study for the TECNIS^® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of < 1.0 diopter. The TECNIS^® Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS^® Toric 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.

PRECAUTIONS

Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Do not soak or rinse with any solution other than sterile balanced salt solution or sterile normal saline. Do not store in direct sunlight or at greater than  113°F. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS^® Toric 1-Piece IOL with the intended axis of placement. When the insertion system is used improperly, the haptics of the TECNIS^®Toric 1-Piece IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. The use of methods other than the TECNIS Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the clinical study and may not yield similar results. Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions, and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Preexisting conditions include: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, or irregular corneal astigmatism. Intraoperative conditions include: excessive vitreous loss, capsulotomy by any technique other than a circular tear, the presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular tear cannot be confirmed by direct visualization, cataract extraction by techniques other than phacoemulsification or liquefaction, situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.), capsular rupture, significant anterior chamber hyphema, uncontrollable positive intraocular pressure, zonular damage. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS Toric intraocular lens labeling. Please refer to the TECNIS Toric Calculator user manual for more information. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the clinical study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Do not reuse, resterilize, or autoclave.

ADVERSE EVENTS

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, pupillary block, retinal detachment, IOL dislocation, persistent corneal stromal edema, persistent cystoid macular edema, or secondary surgical intervention (including implant repositioning, removal, or other surgical procedure). The most frequently reported cumulative adverse event that occurred during the TECNIS^® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included cystoid macular edema which occurred at a rate of 2.9% and retinal detachment which occurred at a rate of 0.6%.

 

SENSAR^® 1-Piece IOL

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE SENSAR^® 1-PIECE IOL

Rx Only

INDICATIONS

SENSAR^® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

PRECAUTIONS

Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not reuse lens. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the SENSAR^® 1-Piece Lens may become damaged.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: patients with recurrent severe anterior or posterior segment inflammation or uveitis, patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss), a compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, circumstances that would result in damage to the endothelium during implantation, suspected microbial infection, and patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. Johnson & Johnson Surgical Vision, Inc. IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/ or illness due to product contamination, transmission of infection, and lack of product sterility. The SENSAR^® 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

ADVERSE EVENTS

The most frequently reported cumulative adverse event that occurred during the clinical trial of the lens was cystoid macular edema, which occurred at a rate of 3.3%. Other reported adverse events include lens exchange and secondary surgical intervention, which occurred at a rate of 0.8%.

ATTENTION

Reference the labeling for a complete listing of Important Indications and Safety Information.

 

TECNIS^® 1-Piece IOLs

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS^® 1-PIECE IOL

Rx Only

INDICATIONS

TECNIS^® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

PRECAUTIONS

Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the TECNIS^® 1-Piece Lens may become damaged.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the TECNIS^® 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These conditions include recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The TECNIS^® 1-Piece IOL should not be placed in the ciliary sulcus.

ADVERSE EVENTS

In 3.3% of patients, reported adverse events of cataract surgery with the 1-Piece IOL included macular edema. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).

 

TECNIS^® CL IOL

IMPORTANT SAFETY INFORMATION FOR TECNIS^® CL 3-PIECE IOLs

Rx Only

INDICATIONS

TECNIS^® CL Silicone intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. These conditions include: patients with recurrent severe anterior or posterior segment inflammation or uveitis, patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss), a distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, circumstances that would result in damage to the endothelium during implantation, suspected microbial infection, patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL, since the clinical study of parent lens model 911A was conducted with the lens implanted in the capsular bag, there are insufficient clinical data to demonstrate the safety and efficacy for placement in the ciliary sulcus, children under the age of 2 years are not suitable candidates for intraocular lenses, the use of silicone lenses in patients with current vitreoretinal disease or those who are at high risk for future vitreoretinal disease that may require silicone oil as part of therapy should be reconsidered. Johnson & Johnson Surgical Vision, Inc. IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

Do not resterilize the lens as this can produce undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 45°C. Do not autoclave the intraocular lens. Avoid exposure to volatile chemicals. Do not reuse the lens.

ADVERSE EVENTS

The most frequently reported adverse event that occurred during the clinical trials of the parent lens models for the TECNIS^® CL intraocular lens was corneal edema (upper and lower corneal edema), which occurred at a combined rate of 10.9%. The second most frequent adverse event was iritis, which occurred at a rate of 7.9%. Macular edema was the third most frequently reported adverse event, which occurred at a rate of 3.8%. Other reported reactions occurring in less than 2% of patients were hyphema, secondary glaucoma, cyclitic membrane, vitritis, surgical intervention (penetrating keratoplasty, lens replacement, and lens removal, lens repositioning, wound leak repair, and focal laser therapy), corneal decompensation and endophthalmitis.

 

One Series Ultra Delivery System

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE ONE SERIES ULTRA CARTRIDGE IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The DK7786 handpiece with the One Series Ultra cartridge implantation system is used to fold and assist in inserting TECNIS Acrylic 1-Piece intraocular lenses (IOL), ONLY into the capsular bag.

CONTRAINDICATIONS

Do not use the handpiece if the rod tip appears nicked or damaged in any way.

WARNINGS

The DK7786 handpiece with the One Series Ultra cartridge implantation system should only be used with TECNIS  Acrylic 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Use of methylcellulose viscoelastics is not recommended as they have not been validated with this implantation system. Do not implant lens if rod tip becomes jammed in the cartridge.

PRECAUTIONS

The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the HEALON^® Family of Viscoelastics. Do not use balanced salt solution. The combination of low operating room temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of this implantation system has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F (5°C) or over 86°F (30°C).

ATTENTION

Reference the labeling for a complete listing of Indications and Important Safety Information

 

TECNIS iTec^® Preloaded Delivery System

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® 1-PIECE IOL WITH TECNIS iTEC^® PRELOADED DELIVERY SYSTEM

Rx Only

INDICATIONS

The TECNIS^® 1-Piece Lens is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients with recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL; children under the age of 2 years are not suitable candidates for intraocular lenses. Do not attempt to disassemble, modify or alter this device or any of its components, as this can significantly affect the function and/or structural integrity of the design. Use of methylcellulose viscoelastics is not recommended as they have not been validated for use with the TECNIS iTec^®Preloaded Delivery System. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the cartridge. Do not push the plunger forward to fully advance the lens until ready for lens implantation. Discard the device if the lens has been fully advanced for more than 1 minute. JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the TECNIS iTec^® Preloaded Delivery System minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of JJSV single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. The TECNIS^® 1-piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

PRECAUTIONS

Do not resterilize the lens or the TECNIS iTec^® Preloaded Delivery System. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the device. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C. The combination of low operating room temperatures and high IOL diopter powers may require slower delivery. The use of viscoelastics is required when using the TECNIS iTec^® Preloaded Delivery System. For optimal performance, use the JJSV HEALON^® family of viscoelastics. The use of balanced salt solution alone is not recommended. Do not use if the TECNIS iTec^® Preloaded Delivery System has been dropped or if any part was inadvertently struck while outside the shipping case.

ADVERSE EVENTS

In 3.3% of patients, reported adverse events of cataract surgery with the 1-Piece IOL included macular edema. Other reported events occurring in less than 1% of patients were secondary surgical intervention (0.8%, vitrectomy) and lens exchange (0.8%, due to torn lens haptic).

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

 

UNFOLDER^® Delivery Systems

INDICATIONS AND IMPORTANT SAFETY INFORMATION

FOR THE UNFOLDER^® PLATINUM 1 SERIES IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The Model DK7796 Handpiece is used in combination with the Model 1MTEC30 Cartridge to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-Piece Intraocular Lenses, ONLY into the capsular bag.

CONTRAINDICATIONS

Do not use the handpiece if the rod tip appears nicked or damaged in any way.

WARNINGS

The UNFOLDER^® Platinum 1 Series Implantation System should be used ONLY with JJSV Acrylic 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with the Model 1MTEC30 Cartridge and JJSV acrylic 1-Piece IOLs. Do not implant lens if rod tip becomes jammed in the cartridge. JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the JJSV HEALON^® Family of Viscoelastics. Do not use balanced salt solution. The combination of low operating room temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of the UNFOLDER^®Platinum 1 Series Implantation System has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F or over 86°F.

FOR THE UNFOLDER^® EMERALD IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The UNFOLDER^® Emerald Series Implantation System is used to fold and assist in inserting JJSV Acrylic OptiEdge intraocular lenses, ONLY into the capsular bag.

WARNINGS

The UNFOLDER^® Emerald Series Implantation System should only be used with JJSV acrylic OptiEdge IOLs. Do not use this device or any of its components with any other lens. If the cartridge tip is cracked or split prior to implantation, do not use. The lens and cartridge should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position within the cartridge for more than 5 minutes. Never reverse the rod direction until the optic body has been completely released. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. If the IOL is not properly placed in the cartridge, the lens may flip and be implanted upside down. The UNFOLDER^® Emerald Series Cartridge is intended for single use only. Discard after a single use. Do not autoclave or resterilize by any method. Do not advance an intraocular lens through a given cartridge more than once. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design.

WARNINGS (CARTRIDGE ONLY)

JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Overall system performance will be impaired when used in combination with non-JJSV products. The use of viscoelastics is required when loading the IOL into the UNFOLDER^® Emerald Cartridge. Do not use balanced salt solution. Do not use if the instrument has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F or over 86°F. Inconsistent results have been found when using some methylcellulose viscoelastics. Avoid using these viscoelastics if high forces are observed while advancing the intraocular lens through the cartridge.

FOR THE UNFOLDER^® SILVER SERIES IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The UNFOLDER^® Silver Series Implantation System is used to fold and assist in inserting CLARIFLEX, PHACOFLEX II, CeeOn, TECNIS^®Silicone, and ARRAY Silicone ≤ 24.0 D IOLs only, into the eye. 

WARNINGS

The UNFOLDER^® Silver Series Implantation System should only be used with silicone IOLs. Do not use this device or any of its components with any other lens. If the cartridge tip is cracked or split prior to implantation, do not use. Never release the rod direction until the optic body has been completely released. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. The lens, cartridge and sheath should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. The UNFOLDER^® Silver Series Cartridge is intended for single use only. JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. Do not advance an IOL through a given cartridge more than once. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Never use the UNFOLDER^® Silver Series Implantation System without a SofTip Sheath applied to the end of the handpiece rod. Always ensure that the SofTip Sheath is fully engaged on the handpiece rod tip. If it is not, use your sterile-gloved finger to engage the tip firmly against the shoulder of the rod. Avoid methyl cellulose viscoelastics. Follow the dwell recommendations for advanced position of the IOL.

PRECAUTIONS

The contents of the cartridge package are sterile when tray is sealed and undamaged. Overall system performance will be impaired when used in combination with non-JJSV products. The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the JJSV HEALON^® Family of Viscoelastics. Do not use balanced salt solution. Do not use if any component of this implantation system has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 5°C or over 30°C.

ATTENTION

Reference the labeling for a complete listing of Indications and Important Safety Information.

 

 

UNFOLDER Vitan™ Inserter

INDICATIONS & IMPORTANT SAFETY INFORMATION FOR UNFOLDER Vitan™ Inserter

Rx Only

INDICATIONS FOR USE 

The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson and Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.

Precautions 

1. Do not use if any component of the UNFOLDER Vitan™ Inserter has been dropped or inadvertently struck while outside of the shipping case.

Warnings 

1. Do not use if the cartridge of the SmartLOAD™ Delivery Technology is cracked or split prior to implantation.

2. During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens.

3. After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge.

4. The lens and SmartLOAD™ Delivery Technology should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge.

5. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design.

6. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with the SmartLOAD™ Delivery Technology.

7. The use of enzymatic cleaners and detergents is not recommended due to the potential for Toxic Anterior Segment Syndrome (TASS).

8. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the SmartLOADTM Delivery Technology.

9. Do not use the inserter if the rod tip appears nicked or damaged in any way because the rod may override and/or damage the IOL resulting in the need to exchange the IOL.

10. Do not sterilize the UNFOLDER Vitan™ inserter prior to performing the cleaning procedure.

Warning (SmartLOAD™ Delivery Technology ONLY) 

Johnson and Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing for Johnson and Johnson Surgical Vision, Inc. single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

 

TECNIS® 1-Piece IOL with TECNIS Simplicity™Delivery System

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Rx Only

INDICATIONS FOR USE 

The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS® 1-Piece intraocular lens for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

Precautions 

1. This is a single use device, do not resterilize the lens or the TECNIS Simplicity™ Delivery System. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects.2. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F).3. Do not autoclave the TECNIS Simplicity™ Delivery System.4. Do not advance the lens unless ready for lens implantation.5. The contents are sterile unless the package is opened or damaged.6. The recommended temperature for implanting the lens is at least 17°C (63°F).7. The use of balanced salt solution (BSS) or viscoelastics is required when using the TECNIS Simplicity™ Delivery System. For optimal performance when using OVD, use the HEALON® family of viscoelastics. The use of BSS with additives has not been studied for this product.8. Do not use if the TECNIS Simplicity™ Delivery System has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the TECNIS Simplicity™ Delivery System and/or the lens may have been compromised.9. Do not leave the lens in a folded position for more than 10 minutes. When the insertion system is used improperly, the haptics of the TECNIS® 1-piece lens may become damaged.

Warnings 

1. Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:a. Patients with recurrent severe anterior or posterior segment inflammation or uveitis.b. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases.c. Surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss).d. A compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.e. Circumstances that would result in damage to the endothelium during implantation.f. Suspected microbial infection.g. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL.h. Children under the age of 2 years are not suitable candidates for intraocular lenses.

2. Do not attempt to disassemble, modify or alter the TECNIS Simplicity™ Delivery System or any of its components, as this can significantly affect the function and/or structural integrity of the design.

3. Do not use if the cartridge of the TECNIS Simplicity™ Delivery System is cracked or split prior to implantation.

4. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the TECNIS Simplicity™ Delivery System.

5. During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens.

6. After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge.

7. The lens and TECNIS Simplicity™ Delivery System should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge.

8. Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the TECNIS Simplicity™ Delivery System minimizes the risk of infection and/or inflammation associated with contamination.

9. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

10. The TECNIS® 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

11. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with the TECNIS Simplicity™ Delivery System.

Adverse Events 

As of August 10, 2007, the incidence of adverse events experienced during the clinical trial for Model AAB00 is similar to or less than those of the historic control population (FDA Grid for posterior chamber IOLs).

 

TECNIS® Synergy IOL

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Rx Only

INDICATIONS FOR USE 

The lens model ZFR00 is indicated for primary implantation for the visual correction of: [1] aphakia in adults in whom a cataractous lens has been removed, and [2] aphakia following refractive lensectomy in presbyopic adults who may benefit from useful near vision and reduced spectacle dependence across a range of distances. The lens is intended to be placed in the capsular bag.

PRECAUTIONS 

1. When performing refraction in patients implanted with the lens model ZFR00, interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is strongly recommended.

2. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design.

3. Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power.

4. Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects.

5. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline.

6. Do not store the lens in direct sunlight or at a temperature greater than 45°C (113°F). Do not autoclave the intraocular lens.

7. Do not re-use the lens.

8. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date.

9. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved.

10. Care should be taken to achieve centration of the intraocular lens.

11. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded.

12. When the insertion system is used improperly, the haptics of the IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system.

13. Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient.

14. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies.

15. A patient implanted with an intraocular lens should be monitored on a regular basis for long-term postoperative follow-up.

16. The intraocular pressure of implanted patients with glaucoma should be carefully monitored for postoperative changes.

WARNINGS 

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

1. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient’s eyesight: a. Recurrent severe anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye. b. Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat posterior segment diseases. c. Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss) d. A compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible. e. Circumstance that would result in damage to the endothelium during implantation. f. Suspected microbial infection. g. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support for the IOL. h. Congenital bilateral cataracts. i. Previous history of, or a predisposition to, retinal detachment. j. Patients with potentially good vision in only one eye. k. Medically uncontrollable glaucoma. l. Corneal endothelial dystrophy. m. Proliferative diabetic retinopathy. n. Children under the age of 2 years are not suitable candidates for intraocular lenses.

2. The lens model ZFR00 should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

3. Well-informed patients with well-defined visual needs and preferences should be selected for lens model ZFR00 implantation. The patients should be informed of the possibility of visual effects (such as halo or glare) in nighttime or poor visibility conditions. Patients may perceive these visual effects as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL.

4. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for lens model ZFR00 implantation since they may not fully benefit in terms of potential spectacle independence.

5. The lens model ZFR00 may affect image quality and lead to some reduction of contrast sensitivity compared to a monofocal lens. Therefore, patients should exercise caution when driving at night or in poor visibility conditions.

6. Johnson & Johnson Surgical Vision, Inc. IOLs are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The resterilization/ reprocessing of Johnson & Johnson Surgical Vision, Inc. IOLs may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

 

 

TECNIS® Eyhance 1-Piece IOL

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Rx Only

INDICATIONS FOR USE 

The TECNIS Eyhance IOL, model ICB00, is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens extends the depth of focus, which improves vision for intermediate tasks, and provide similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only.

PRECAUTIONS 

1. Autorefractors may not provide optimal postoperative refraction of patients with TECNIS Eyhance IOL, model ICB00, lenses. Manual refraction with maximum plus technique is strongly recommended.

2. Recent contact lens usage may affect the patient’s refraction; therefore, for patients that wear contact lenses, surgeons should establish corneal stability without contact lenses prior to determining IOL power.

3. Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects.

4. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline.

5. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens.

6. Do not re-use the intraocular lens.

7. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date.

8. The lens is designed for optimum visual performance when emmetropia is targeted.

9. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded.

10. When the insertion system is used improperly, the haptics of the TECNIS Eyhance IOL, model ICB00, may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system.

WARNINGS 

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

1. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient’s eyesight. These conditions are not specific to the design of the lens and are attributed to cataract surgery and IOL implantation in general: a) Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye. b) Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases. c) Surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss). d) A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible. e) Circumstances that would result in damage to the endothelium during implantation. f) Suspected microbial infection. g) Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. h) Congenital bilateral cataracts. i) Previous history of, or a predisposition to, retinal detachment. j) Patients with only one good eye with potentially good vision. k) Medically uncontrollable glaucoma. l) Corneal endothelial dystrophy. m) Proliferative diabetic retinopathy. n) Children under the age of 2 years are not suitable candidates for intraocular lenses.

2. The TECNIS Eyhance IOL, model ICB00, should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus.

3. Johnson & Johnson Surgical Vision, Inc. IOLs are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The resterilization/reprocessing of the IOLs may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

TECNIS® Toric II 1-Piece IOL

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Rx Only

INDICATIONS FOR USE 

The TECNIS® Toric II 1-Piece posterior chamber lenses are indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS 

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

1. Patients with recurrent severe anterior or posterior segment inflammation or uveitis.

2. Surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss).

3. A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible.

4. Circumstances that would result in damage to the endothelium during implantation.

5. Suspected microbial infection.

6. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL.

7. Children under the age of 2 years are not suitable candidates for intraocular lenses.

8. The clinical study for the TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter.

9. The TECNIS® Toric II 1-Piece IOL should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus.

10. Rotation of the TECNIS® Toric II 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.

PRECAUTIONS 

1. Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient.

2. Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects.

3. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline.

4. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens.

5. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS® Toric II 1-Piece IOL with the intended axis of placement.

6. When the insertion system is used improperly, the haptics of the TECNIS® Toric II 1-Piece lens may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system.

7. The use of methods other than the TECNIS Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the clinical study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes.

8. The safety and effectiveness of the TECNIS® Toric II 1-Piece IOLs have not been substantiated in patients with the following preexisting ocular conditions and intraoperative complications (see below). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Before Surgery • Choroidal hemorrhage • Chronic severe uveitis • Concomitant severe eye disease • Extremely shallow anterior chamber • Medically uncontrolled glaucoma • Microphthalmos • Non-age-related cataract • Proliferative diabetic retinopathy (severe) • Severe corneal dystrophy • Severe optic nerve atrophy • Irregular corneal astigmatism During Surgery • Excessive vitreous loss • Capsulotomy by any technique other than a circular tear • The presence of radial tears known or suspected at the time of surgery • Situations in which the integrity of the circular tear cannot be confirmed by direct visualization • Cataract extraction by techniques other than phacoemulsification or liquefaction • Situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.) • Capsular rupture • Significant anterior chamber hyphema • Uncontrollable positive intraocular pressure • Zonular damage

9. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS Toric intraocular lens labeling. Please refer to the Johnson & Johnson Surgical Vision, Inc. Toric Calculator user manual for more information.

10. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes, and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism.

11. All corneal incisions were placed temporally in the clinical study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options.

GENERAL ADVERSE EVENTS FOR IOLS 

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to:

• Endophthalmitis/intraocular infection

• Hypopyon

• Pupillary block

• Retinal detachment

• IOL dislocation

• Persistent corneal stromal edema

• Persistent cystoid macular edema

• Secondary surgical intervention (including implant repositioning, removal, or other surgical procedure)

• Any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment

ADVERSE EVENTS 

The incidence rates of cumulative events for the TECNIS® Toric 1-Piece IOL first eyes in the clinical study compared to ISO SPE rates are presented in Table 22. The incidence rates for the TECNIS® Toric ZCT IOL first eyes compared favorably to the ISO SPE rates. Only the rate of surgical re-intervention (3.4%; 6/174) was statistically significantly higher than the ISO SPE rate of 0.8%. Four lens-related, repositioning procedures were performed in toric eyes to correct a rotated IOL; however the rate for repositioning procedures (2.3%; 4/175) alone was not statistically significantly higher than the ISO SPE rate for surgical re-intervention. The lens repositioning procedures occurred in ZCT300 and ZCT400 first eyes only (7.3%; 4/55); no ZCT300 or ZCT400 second eyes underwent lens repositioning procedures, thereby yielding an overall rate of 4.7% (4/85) for all ZCT300 and ZCT400 eyes. The rate of non-lensrelated re-interventions (two retinal repair procedures; 1.1%, 2/174) was not statistically significantly higher than the ISO SPE rate for surgical re-intervention. There were no persistent medical complications present at six months for toric first eyes in comparison to the ISO SPE rates for persistent complications. Additionally, no adverse events occurred in toric second eyes (0%; 0/149) or for any ZCB00 control eyes. IOL rotation was noted by investigators at one day postoperatively in four toric first eyes; these were the four eyes (two ZCT300 and two ZCT400) that underwent IOL repositioning procedures in the study. IOL rotation at one day was estimated by the investigators to be 10° in both ZCT300 eyes, 35° in one ZCT400 eye, and 40° in the other ZCT400 eye. The repositioning procedures were performed early in the postoperative period, between the 1-day and 1-month study visits. Photographic analyses showed good lens stability following the repositioning procedures with only 2° to 5° of calculated rotation at six months vs. following the repositioning procedures.

The incidence of adverse events experienced during the clinical trial for Model AAB00 is similar to or less than those of the historic control population (FDA Grid/ISO SPE rates for posterior chamber IOLs)

TECNIS® Monofocal 1-Piece IOL

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Rx Only

PRECAUTIONS 

Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the TECNIS® 1-Piece Lens may become damaged.

WARNINGS 

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the TECNIS® 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These conditions include recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The TECNIS® 1-piece IOL should not be placed in the ciliary sulcus.

ADVERSE EVENTS 

In 3.3% of patients, reported adverse events of cataract surgery with the 1-Piece IOL included macular edema. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).