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The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

The EyeGility Inserter is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

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 Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052. A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168). The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience. The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017. This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM. The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

Samfilcon B Contact Lens: Bausch + Lomb Samfilcon B Contact Lens for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. Samfilcon B Contact Lens for Astigmatism: Bausch + Lomb Samfilcon B Contact Lens for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, hyperopia and/or astigmatism) in aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters. Samfilcon B Contact Lens for Presbyopia: Bausch + Lomb Samfilcon B Contact Lens for Presbyopia for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. Samfilcon B Contact Lens Multifocal for Astigmatism: Bausch + Lomb Samfilcon B Contact Lens Multifocal for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, and/or astigmatism) and presbyopia in aphakic and not aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters. When prescribed for frequent planned replacement wear, the contact lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system. The Samfilcon B Contact Lens is available for a frequent/planned replacement modality.

The Bausch + Lomb Samfilcon B Contact Lens is made from a silicone hydrogel material and is approximately 41% water by weight when immersed in a sterile phosphate buffered saline solution. This lens is tinted blue with Reactive Blue Dye 246. The color additive conforms with 21 CFR Part 73.3106. The Bausch + Lomb Samfilcon B Contact Lens is to be prescribed for daily wear. The custom-made lenses will be manufactured in spherical, toric, multifocal and toric multifocal designs with the following parameters: Diameter: 10.0 mm to 16.0 mm Base Curve: 6.5 mm to 9.7 mm Power Range: +20.00D to -20.00D Cylinder Power (Toric): 0D to -10.00D Cylinder Axis: 1° to 180° Add Power (Multifocal): +0.50D up to +4.00D The lenses are packaged in borosilicate USP Type 1 glass vials containing phosphate buffered saline solution. A silicone vial stopper and aluminum crimp cap secure the lenses in the vial. Vials are labeled with lot number, expiration date and applicable lens parameters. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process.

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens maybe prescribed in spherical powers ranging from +20.00D to -20.00D. Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters. Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuty. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D. The lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.

The Bausch + Lomb kalifilcon A material is made from a hvdrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with poloxamine, poloxamer 181, qlycerin, erythritol, and polyguaternium. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246. The Bausch + Lomb kalifilcon A Contact Lenses are to be prescribed for single-use disposable wear. The physical properties of the lenses are: Refractive index: 1.4011 Light transmission: 97% Water Content: 55% Specific Gravity: 1.029 Oxygen Permeability: 107 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method) The lenses will be manufactured in spherical, toric and multifocal designs with the following parameters: Diameter: 13.5mm to 15.0mm Center Thickness: 0.05mm to 0.75mm Base Curve: 7.8mm to 9.5mm Power Range: +20.00D to -20.00D Cylinder Power (Toric): -0.75D to -5.00D Cylinder Axis: 0° to 180° Add Power (Multi-Focal): +0.75D to +5.00D The lenses are packaged in disposable blister packages containing phosphate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process.

Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.

Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear.

The Independent Viewing Chamber (IVC-21) is a sterile container that may be used for the transportation of corneal tissue preserved in Optisol GS storage media.

The Independent Corneal Viewing Chamber (IVC) is a sterile container (consisting of a jar, lid, and o-ring) that may be used for transportation of corneal tissue preserved in Optisol GS storage media.

Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

Bausch + Lomb ABT12 multi-purpose solution is a sterile isotonic aqueous solution [containing polyaminopropyl biguanide (0.0005%), polyquaternium (0.00015%), and alexidine (0.00025%)] for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft (hydrophilic) and silicone hydrogel contact lenses. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D. The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

The Bausch + Lomb kalifilcon A material is made from a hydrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline solution with poloxamine, poloxamer 181, glycerin, and erythritol. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246. The multifocal lenses will be manufactured with the following parameters: Diameter 13.5mm to 15.0mm, Center Thickness 0.05mm to 0.75mm, Base Curve 7.8mm to 9.5mm, Power Range +20.00D to -20.00D, Add Power (Multifocal) +0.75D to +5.00D. The lenses are packaged in disposable blister packages containing phosphate buffered saline solution.

Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.

Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.