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The LenSx Laser system is indicated for use: - In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery. - In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery. - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. - In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system. The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application. The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism. Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. Dailies Total1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. Dailies Total1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia. with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. Dailies Total1 for Astigmatism (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism. Dailies Total 1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. Dailies Total1 lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Precision1 (P1) (verofilcon A lens material) and Dailies Total1 (DT1) (delefilcon A) are soft contact lenses, intended for on-eye use in persons with healthy eyes that need vision correction as determined and fitted by an eye care professional. The lensed for single use, daily disposable wear (less than 24 hours while awake) only. Precision1 (verofilcon A) and Dailies Total1 (delefilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foil-blister packs, which are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packs are packaged into carton boxes available in different pack sizes. Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric (for astigmatism) lens design. Dailies Total 1 (delefilcon A) soft contact lenses are available in spherical, toric (for astigmatism) and multifocal toric lens designs.

Alcon 27GA Chandelier The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery. Alcon 27+ DS Wide Angle Endoilluminator The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery. Alcon 27+ DS Endoilluminator The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.

As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024). Alcon 27GA Chandelier: The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum. Alcon 27+ DS Wide Angle Endoilluminator: The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models. Alcon 27+ DS Endoilluminator: The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.

UNITY VCS: The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures. UNITY CS: The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.

The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuumcontrolled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device. When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting. The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation. The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network. Both devices are for prescription use only.

The Centurion™ Vision System (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material 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 functionality of injection of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof ™ lenses SN60WF. SN6AD1, 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 to provide 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 extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the eye, while replacing aspirated fluid and lens material with balanced salt solution (BSS™). 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.

Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism. Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. TOTAL30 (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. TOTAL30 for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction ofrefractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes with up to 6.00 diopters (D) of astigmatism. TOTAL30 Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. TOTAL30 lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.

Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric lens design. Precision1 (verofilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foilblister packs, which are terminally sterlized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packaged into carton boxes available in different pack sizes. Lehfilcon A soft contact lenses are available in a spherical design (for correction of vision in persons with myopia or hyperopia), toric design (for correction of myopia, with astigmatism) and multifocal design (for correction of presbyopia, with or without myopia or hyperopia) in a range of powers and parameters. Lehfilcon A lenses immersed in package saline and provided sterile in sealed blister packages are fully functioning (i.e., ready to use) out of pack (no need for accessories). Lenses in sealed blister packs (primary packaging) are provided in an outer carton (secondary packaging). For daily wear/reuse, products such as commercially available soft contact lens care cleaning and disinfecting solutions, rewetting drops, saline solutions and contact lens cases may be used. Accessories are sold and provided separately from the device.

DAILIES TOTAL 1® (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. DAILIES TOTAL1® Toric (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism. DAILIES TOTAL 1® Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. DAILIES TOTAL 1® Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES TOTAL 1® (delefilcon A) soft contact lenses may be made available in sphere, toric, multifocal, and multifocal toric lens designs. The lens material, delefilcon A, is a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. When hydrated and placed on the cornea, DALIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina. It is considered a Group 5C material according to ISO 18369-1:2017. The lenses have a light blue tint that makes to see when handling. The modified lenses are tinted using Reactive Blue 247. The lenses are cast-molded and have a water gradient surface treatment. Lenses may be made available in the following parameter range: - Diameter: 13.0 to 15.0 mm - Base Curve: 8.0 to 9.2 mm - Power Range: +20.0 D to -20.0 D - Center Thickness: 0.070 mm to 0.340 mm (varies with power) - Cylinder Power: Up to 5.00 D - Cylinder Axis: 1° to 180° - ADD power: Up to 5.00 D Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution with polymeric wetting agents that form the water gradient surface.

Precision1 (verofilcon A) Spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism. The lenses are to be prescribed for single use, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric lens design. Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism. Precision 1 (verofilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foilblister packs, which are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packaged into carton boxes available in different pack sizes.

AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses with refractive power are indicated for daily wear for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes and up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. AIR OPTIX® COLORS (lotrafilcon B) toric soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism. AIR OPTIX® COLORS (lotrafilcon B) multifocal soft contact lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye. The lenses may be prescribed for frequent/planned replacement wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

The lens material of AIR OPTIX® COLORS is 33% water and 67% lotrafilcon B, a fluorosilicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group 5 (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2017. A cosmetic pattern is embedded into the back surface of the lens, containing a combination of the following color additives: carbazole violet, iron oxides, [phthalocyaninato (2-)] copper, phthalocyanine green and titanium dioxide. Cleared lens designs for AIR OPTIX® COLORS (lotrafilcon B) include spherical, toric, and multifocal lenses in the following parameter range: • Diameter Range: 13.0 to 15.0 mm • Base Curve Range: 8.0 to 9.2 mm • Power Range: -20.00 D to +20.00 D • Center Thickness: varies with design and power (0.08 mm for -3.00 D spherical) Lenses have the following properties: • Refractive index: 1.42 (hydrated) • Luminous transmittance: 95 ± 5% • Water content: 33% by weight in normal saline • Oxygen permeability: 110 x 10-11 (cm²/sec)(ml O₂ /ml x mm Hg), measured at 35 °C (intrinsic Dk – Coulometric method) Lenses are supplied sterile in sealed blister packs containing phosphate buffered saline solution (PBS) with 1% Copolymer 845 (labeled as buffered saline containing 0.2% VP/DMAEMA Copolymer). The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lens color, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to further extend the labeled expiration date.

Alcon (serafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astignatism that does not interfere with visual acuity. Alcon for Astigmatism (serafileon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism. Alcon Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Alcon Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. The lenses are to be prescribed for daily wear with removal for disposal, or cleaning and heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded with a new pair each week, or more often, if recommended by the eye care professional.

The subject device is made from a silicone containing hydrogel lens material that is approximately 55% water and 45% serafilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edge-to-edge color to make it easier to see when handling. In addition, lenses contain two benzotriazole monomers to block UVA and UVB radiation, and additionally, reduce transmittance in the range of 380 nm to 450 nm. Serafilcon A represents a Group 5B silicone hydrogel contact lens material ('enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications. Serafilcon A lens designs include spherical, toric, multifocal toric lenses in the following parameter ranges: - Diameter Range: 13.0 to 15.0 mm - Base Curve Range: 8.0 to 9.2 mm - Power Range: -20.00 D to +20.00 D - Center Thickness: varies with design and power (Example: 0.08 mm for -3.00 D spherical) - Cylinder Power (toric) Range: -0.25 D to -10.00 D - Cylinder Axis (toric) Range: 001 to 180° - ADD Power (multifocal) Range: LO, MED, HI Lenses have the following properties: - Refractive index: 1.40 (hydrated) - Water content : 55% by weight in normal saline - Oxygen permeability: 119 x 10 -11 [(cm2 /sec)(ml O2 /mlommHg)] measured at 35 °C (normalized Dk-Polarographic method) - Light transmittance: ≥85% - UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 to 380 nm for the entire power range. Serafilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents.