Indications and Important Safety Information

Crystalens^® posterior chamber accommodating IOL

INDICATIONS FOR USE: The Crystalens^® posterior chamber accommodating intraocular lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. Crystalens^® provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles.

WARNINGS: The safety and effectiveness of the Crystalens^® AO IOL has not been established in patients with preexisting conditions. Careful preoperative evaluation and sound clinical judgement should be used by the surgeon to decide the risk / benefit ratio before implanting a lens in a patient with conditions as outlined in the Crystalens^® AO IOL Directions for Use. Unlike most other IOLs, the Crystalens^® AO IOL optic has hinges connecting it to the haptic; please see adverse events section below for more information.

PRECAUTIONS: Do not resterilize this intraocular lens by any method. Do not store lenses at temperatures over 45°C (113°F). Do not implant this lens in the anterior chamber or the ciliary sulcus.

ADVERSE EVENTS: The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. Vaulting is a post-operative adverse event where the Crystalens^® AO IOL optic hinges move into and remain in a displaced configuration. If vaulting occurs, please see Directions for Use for a detailed listing of symptoms, information regarding diagnosis, potential causes, and sequelae. Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

TRULIGN^® toric posterior chamber IOL

INDICATIONS: The TRULIGN^® toric posterior chamber intraocular lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.

WARNINGS: Careful preoperative evaluation and sound clinical judgement should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient. Rotation of toric lenses away from their intended axis can reduce their effectiveness, and misalignment can increase postoperative refractive cylinder. The TRULIGN^® Toric IOL should only be repositioned when the refractive needs of the patient outweigh the potential risks inherent in any surgical reintervention into the eye. Unlike most other IOLs, the TRULIGN^® Toric IOL optic has hinges connecting it to the haptic; please see adverse events section below for more information.

PRECAUTIONS: The safety and effectiveness of the TRULIGN^® Toric intraocular lenses have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Long-term stability in the human eye has not been established; therefore postoperative monitoring after implant should be performed on a regular basis. The potential for the lens to rotate causing misalignments that will reduce the effectiveness of the TRULIGN^® Toric IOL may be greater in some eyes. Lens rotation less than 5° may not warrant reorientation. Do not resterilize this intraocular lens by any method. Do not store lenses at temperatures over 45°C (113°F). 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 conditions as outlinedin the TRULIGN^® Toric IOL directions for use.

ADVERSE EVENTS: The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. Vaulting is a post-operative adverse event where the TRULIGN^® Toric IOL optic hinges move into and remain in a displaced configuration. If vaulting occurs, please see Directions for Use for a detailed listing of symptoms, information regarding diagnosis, potential causes, and sequelae. Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician

enVista^® Preloaded IOL & enVista Toric Preloaded IOL (Model MX60PL & MX60PT) with SimplifEYE™ Inserter

INDICATIONS: The enVista one-piece hydrophobic acrylic IOL (Model MX60PL) is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia following removal of a cataractous lens for improved uncorrected distance vision. The enVista one-piece hydrophobic acrylic toric IOL (Model MX60PT) is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision The SimplifEYE™ Inserter is indicated for folding and inserting of enVista IOLs (Models MX60PL and MX60PT) and IOL models approved for use with this IOL insertion device.

WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk / benefit ratio before implanting a lens in a patient.

PRECAUTIONS: Do not resterilize this intraocular lens or inserter by any method. Do no use if the packaging is damaged or if there are signs of leakage. Do not store lenses or inserter at temperatures over 43°C (109°F) or lower than 0°C (32°F). Do not reuse the lens or inserter. Safety and effectiveness of the enVista IOL and the enVista toric IOL have not been substantiated in patients with conditions and intraoperative complications as outlined in the Directions for Use.

ADVERSE EVENTS: As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon transient or persistent glaucoma, acute corneal decompensation, toxic anterior segment syndrome (TASS), and secondary surgical intervention.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications and important safety information.

Stellaris Elite^® and Accessories

INDICATIONS: The Bausch + Lomb Stellaris Elite^® vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite^® Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

Contraindications

• All Systems: Use of accessories not designated by Bausch + Lomb for use with this equipment may result in serious permanent patient injury, adverse surgical outcome,or damage to the equipment.
• Systems with Laser Module: Photocoagulation is not indicated for patients without pigmentation (albino eyes). In addition, Laser Indirect Ophthalmoscope (LIO) is not indicated for cases involving laser photocoagulation within the arcades.

Warnings

All Systems:

• Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during intraocular surgery.
• Electromagnetic interaction between the phacoemulsification (phaco) handpiece and an implanted cardiac pacemaker is unlikely but cannot be ruled out.

Systems with Laser Module:

• All support personnel who are present during laser treatment must wear appropriate laser protective eyewear.
• DO NOT look directly into the aiming or treatment laserbeam.
• Use of unapproved delivery devices may cause inaccurate laser delivery which could result in serious permanent patient injury.

When using the VITESSE^® handpiece:

• Use only the Entry Site Alignment (ESA) devices provided with the VITESSE^® Handpiece Pack (yellow trocar caps). Do not use any ESA with metal components to avoid particulate in the eye.

When using the FreeFlow™ infusion line:

• Do not attempt to administer intraocular gases or viscous fluids using this device.
• The infusion line loop should be created in the horizontal plane.

General Cautions for Single Use Accessories:

• Do not re-sterilize or reuse any single use accessories.
• Do not use if package integrity / sterile barrier has been breached or compromised.
• Do not use or attempt to repair damaged single use products.

This is not all you need to know. Systems with Laser Module: Misuse of the laser system may lead to dangerous situations and severe injuries. All Systems: See the appropriate Operator Manual for detailed directions, proper use, and full risk and safety information. See individual product instructions for use for detailed information on the use of the VITESSE^® Handpiece, vitrectomy packs and cutters, and the FreeFlow™ infusion line.

CAUTION: Federal (U.S.) Law restricts these devices to sale, by or on the order of a physician.

VICTUS^® femtosecond laser platform

The VICTUS^® femtosecond laser platform is indicated for use for:

• The creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
• For anterior capsulotomy during cataract surgery
• The creations of cuts / incisions in the cornea of patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea
• Laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for posterior subcapsular (PSC) and cortical cataracts

Safety Information

The VICTUS^® femtosecond laser platform emits an invisible class 3B laser beam that may injure the retina of the eyes or burn the skin. Never look directly into the laser source.

Misuse of the laser system may lead to dangerous situations and severe injuries. See the Operator Manual for detailed directions, proper use, and full risk and safety information.

Contraindications

General contraindications for using the VICTUS^® femtosecond laser platform include, but are not limited to, the following: pediatric surgery, hypotony or glaucoma, retinal disorders, rheumatic diseases, occlusion of retinal vessels, pellucid marginal degeneration, existing corneal implant, heavy vascularization of the ocular tissue, epilepsy. Conditions that would cause inadequate clearance between the intended capsulotomy cut and the corneal endothelium. Valid exclusion criteria that complicate the docking procedure. Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light, who show signs of suspected or diagnosed keratoconus, who are pregnant or nursing, who are blind in the fellow eye, patients with any cornea disease in the eye that requires treatment (recurrent corneal erosion, severe basement membrane disease), difference of more than 5D between minimum and maximum K-values of the central 3mm zone on a keratometric map of the cornea, or maximum K-value of more than 60D, or minimum K-value of less than 37D

Potential Complications

Potential general complications resulting from VICTUS^® procedures include, but are not limited to corneal abrasion or defect, pain, bleeding, inflammation, and elevated intraocular pressure.

Please see the Operator Manual for detailed potential procedure-specific complications and contraindications for anterior capsulotomy, corneal cuts / incisions, flaps used in LASIK, and lens fragmentation. Potential complications are not limited to those included in the User Manual.

CAUTION: Federal (U.S.) Law restricts this device to sale, by or on the order of a physician.

Bi-Blade^® Vitrectomy Cutter Important Safety Information

Indications: The Bi-Blade^® Vitrectomy Cutter is a pneumatically actuated device that supports aspiration and guillotine-style cutting functions to remove vitreous and/or other tissues from the eye during surgery. The Bi-Blade^® Vitrectomy Cutter and the Bi-Blade^® Vitrectomy Cutter Packs are intended for use in conjunction with the Stellaris Elite^® or Stellaris PC^® Vision Enhancement Systems, as specified.

Warnings:

• Failure to follow priming instructions for the vitrectomy cutter and aspiration tubing may result in poor aspiration response and reduction in vitrectomy cutter’s effectiveness.
• Do not re-sterilize and do not re-use.
• Only use the Bi-Blade^® Vitrectomy Cutter and Bi-Blade^® Vitrectomy Cutter Packs with the Stellaris Elite^® or Stellaris PC^® Vision Enhancement Systems, as specified.

This is not all you need to know. See the Bi-Blade^® instructions for use for detailed directions, proper use, and full risk and safety information.

CAUTION: Federal (U.S.) Law restricts these devices to sale, by or on the order of a physician.

ADATO® SIL-OL 5000

Indications: ADATO® SIL-OL 5000 is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. ADATO® SIL-OL 5000 is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) related CMV retinitis and other viral infections.

Contraindications: As silicone oil can chemically interact and opacify silicone elastomers, the use of ADATO® SIL-OL 5000 is contraindicated in pseudophakic patients with silicone intraocular lenses (IOLs).

Warnings: Oil-induced pupillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed. In rare instances, silicone oil could migrate out of the eye and form lesions in the conjunctiva or eyelid. The use of CO2 laser should be avoided in the presence of such silicone oil related skin lesions, due to potential ignition.

Precautions:

• ADATO® SIL-OL 5000 is supplied in a sterile syringe intended for single use only and contains no preservative.
• Do not mix oil with any other substances prior to injection.
• An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
• The use of ADATO® SIL-OL 5000 as a long-term tamponade has not been studied and must be determined by the treating physician. ADATO® SIL-OL 5000 should be removed when, in the judgement of the physician, the retinal attachment would not be compromised.

Adverse Events: Adverse events occurring in the highest percentage of patients include cataract, anterior chamber oil migration, keratopathy, and glaucoma. Other less commonly occurring adverse events in greater than 2% of patients include redetachment, optic nerve atrophy, rubeosis iridis, temporary IOP increase, macular pucker, vitreous hemorrhage, phthisis, traction detachment, and angle block. Complications occurring at rates of less than 2% include subretinal strands, retinal rupture, endophthalmitis, subretinal silicone oil, choroidal detachment, aniridia, PVR reproliferation, cystoid macular edema, and enucleation.

Please see ADATO® SIL-OL 5000 package insert for full prescribing and usage information.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.