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The CENTURION® Vision system (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRYSOF intraocular lenses into the eye following cataract removal. The AutoSert IOL Injector Handpiece achieves the function of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN6OWF. SNWAD1. SN6AT3 through SN6AT9. as well as approved ACRYSOF lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Alcon's CENTURION ® Vision System is an ophthalmic surgical instrument designed for use in cataract extraction using the CENTURION® OZil® handpiece, the CENTURION® Active Sentry® handpiece, and the INFINITI® OZil® handpiece. The CENTURION® Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

HyperVit™ Vitrectomy Probe (23, 25 gauge) The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye. HyperVit™ Vitrectomy Probe (27 gauge) The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows: - Vitreous aspiration & cutting - Membrane cutting & aspiration - Lens removal - Dissect tissue in the eye

The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge. The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.

The WaveLight FS200 Laser System is an ophthalmic surgical laser indicated for use: · In the creation of a corneal flap in patients undergoing LASIK surgery or treatment reguiring initial lamellar resection of the cornea. · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. · In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting. · In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea. · In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea.

The WaveLight® FS200 is a stationary scanning-spot femtosecond laser system used to support refractive surgery of the cornea as specified in the indications for use statement.

The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the functionality of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses. Flex-Tip Laser Probes · Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative retinopathy (including diabetic); o Choroidal neovascularization secondary to age-related macular degeneration; o Retinal tears and detachments; o Macular edema; o Retinopathy of prematurity; o Choroidal neovascularization; o Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. · Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. · And other laser treatments including: o Internal sclerostomy; o Lattice degeneration; o Central and Branch Retinal Vein Occlusion; o Suturelysis; o Vascular and pigmented skin lesions. UltraVit Probes · Vitreous aspiration & cutting. Membrane cutting & aspiration. · Lens removal. Endoilluminator Probes · Endoillumination Valved Entry Systems Scleral incision · Canulae for posterior segment instrument access · Venting (of valved cannulae) Infusion Cannulas Posterior segment infusion (liquid or gas)

The CONSTELLATION® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautery, diathermy, and IOL Insertion.

The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

The WaveLight® FS200 Patient Interface 1505 is a patient contact consumable (disposable) consisting of a Tubing System with integrated Suction Ring and an Applanation Cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.

This Monarch® III C Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

The Monarch® III IOL Delivery System (C Cartridge), hereafter referred to as the Monarch® III C Cartridge, is a modification to the previously cleared Alcon Monarch® II IOL Delivery System (C Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III C Cartridge features nozzle tip sizing like the currently marketed Monarch® II C Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the posterior chamber of the eye. The width of the loading zone has been increased to ease loading of 6 mm lenses. The exterior body has been modified, similar to Monarch® III D cartridge to improve manufacturability. It is designed to work with the currently marketed Monarch® III handpiece, and has been qualified for use with Alcon's AcrySof® Intraocular Lens models.

The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses: 27+ UltraVit Probe: Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.) 27+ Flex-Tip Laser Probe: Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.) 27+ Endoilluminator Probe: Endoillumination (The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System) 27+ Valved Entry System: Scleral incision; Canulae for posterior segment instrument access; Venting (of valved cannulae) 27+ Infusion Cannula: Posterior segment infusion (liquid or gas)

The five instruments comprising the 27+ Retina Instrument Set are modified versions of approved larger gauge CONSTELLATION accessories but with smaller diameter instrument tips for less invasive surgery. All other features are exactly the same as the respective predicate devices cleared in K093305, K062624, K063583, and K101285.

ClearCut™ S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.

The ClearCut™ S family of incisional instruments are manual ophthalmic surgical instruments used by surgeons to create surgical incisions during ophthalmic surgical procedures. Incisional instruments incorporating sharps protection features provide injury prevention to those who come in contact with the device. The instruments are designed with an integral guard that can be activated to place the blade in a safe or exposed condition. The product is delivered to the user terminally sterilized by either gamma irradiation or ethylene oxide sterilization methods.

For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Alcon Multi-Purpose Disinfecting Solution (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.

The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use: - · In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. - · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. - · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. - · In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

The WaveLight® FS200 Laser System is a stationary scanning-spot femtosecond laser system used in refractive surgery.