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The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject: 1. cannot be adequately corrected with spectacle lenses 2. requires a rigid gas permeable contact lens surface to improve vision 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process. In the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280mm - 315nm) and >85% in the UVA range (316 - 380nm). The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations.

The Hyper GP (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. The Hyper GP (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The Hyper GP (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Hyper GP (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eves that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The Hyper GP (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process. In the Hyper GP (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280nm = 315nm) and >85% in the UVA range (316 - 380nm). The Hyper GP (tisilfocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17. The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes. The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness. The Hyper GP (tisilfocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters: Base Curve, Center Thickness, Chord Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power. The Hyper GP (tisilfocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters: Base Curve (BC), Center Thickness, Diameter, Secondary Curves, Peripheral Curves, Spherical Power. The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Hyper GP (tisilfocon A) Daily Wear Contact Lens is the Poly Vial Contact Lens Case. When shipped "wet", the Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

The Nutrifill preservative free insertion solution is indicated as an insertion solution for large diameter (scleral), hybrid and rigid gas permeable (RGP) contact lenses following proper lens care disinfection as recommended by the eye care practitioner. This solution may also be used for rinsing debris and lens cleaners from rigid gas permeable, hybrid and hard contact lenses, as a rinse for contact lens cases and may be used as needed throughout the day to rinse contact lenses.

The Nutrifill preservative free insertion solution is a sterile isotonic buffered solution containing electrolytes (calcium, magnesium, phosphate, sodium) in a single dose, carry-on size 10ml vial. It rinses loose debris and cleaning solution off rigid gas permeable (RGP), hard and hybrid contact lenses prior to insertion. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.

OPTIMUM GP (roflufocon D. roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery. Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. OPTIMUM GP (roflufocon D) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject: 1. cannot be adequately corrected with spectacle lenses 2. requires a rigid gas permeable contact lens surface to improve vision 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error. The lenses may be disinfected using a chemical disinfection (not heat) system only.

The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, or hexafocon A-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Water Content, Specific Gravity, Shore D Hardness, Oxygen Permeability (Dk) ISO/FATT Method, Contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D, UV Light Blocking (UVB - 280nm – 315nm; UVA 316nm – 380nm). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available with or without Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability compared to untreated lenses. The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%. The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.

The ENFLU 18 (enflufocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The ENFLU 18 (enflufocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The ENFLU 18 (enflufocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoroitaconate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. In the ENFLU 18 (enflufocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for ENFLU 18 averages > 98% in the UVB range of 280nm - 315nm and >83% in the UVA range of 316 - 380mm. The ENFLU 18 (enflufocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C red No. 17. The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "M Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (enflufocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness. The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

The HEXA100 (hexafocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. The HEXA100 (hexafocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The HEXA100 (hexafocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The HEXA100 (hexafocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The HEXA100 (hexafocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The HEXA100 (hexafocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. In the HEXA100 (hexafocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for HEXA100 averages > 98% in the UVB range of 280nm - 315nm and >84% in the UVA range of 316 - 380nm. The HEXA100 (hexafocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17. The HEXA100 (hexafocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes. The HEXA100 (hexafocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "10 Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible 10 Hydra-PEG, the underlying material (hexafocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%. The HEXA100 (hexafocon A) Daily Wear Contact Lens is available in the Spherical. Toric. Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters: • Chord Diameter: 7.0mm to 22.0mm - Center Thickness: Varies - Base Curve: 5.0mm to 8.0mm - Spherical Powers: -20.00 Diopters to +20.00 Diopters - Toric Powers: up to -10.00 Diopters - Add Powers: up to +4.00 Diopters The HEXA100 (hexafocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters: ● Chord Diameter: 6.5 to 11.5 mm ● Center Thickness: 0.10 to 0.70 mm - Base Curve (BC): 6.5 to 11.0 mm ● Secondary Curves: 0.10 to 2.0 mm (flatter or steeper than BC) ● Peripheral Curves: 0.10 to 2.0 mm (flatter or steeper than BC) - Spherical Powers: -10.00 to +3.00 D

The Optimum GP with HPT (roflufocon C, D, and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only. The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only. The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate. The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (roflufocon C, D, and E) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens are packaged and shipped "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum GP with HPT lenses is the PolyVial Contact Lens Case. The Optimum GP with HPT lenses are packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%. The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17. In the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380mm. The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters: - 7.0mm to 22.0mm Chord Diameter: ● - Center Thickness: Varies - Base Curve: - Spherical Powers: - Toric Powers: - Add Powers: ● 5.0mm to 8.0mm -20.00 Diopters to +20.00 Diopters up to -10.00 Diopters - up to +4.00 Diopters

The OPTIMUM GP OK contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6. C.I. Solvent yellow No. 18. and FD&C Red No. 17. In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm – 315nm and 95% in the UVA range of 316 – 380nm.

The CONTAFLEX 54 (hioxifilcon D) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (nyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. The CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The CONTAFLEX 54 Spherical Soft (hydrophilic) Contact Lenses are fabricated from hioxifilcon D, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2.3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are: Refractive Index 1.5193 (hydrated) Light Transmission (clear) greater than 96% Light Transmission (tinted) greater than 96% Water Content 54 % ± 2% Specific Gravity (wet) 1.120 Oxygen Permeability 20.96 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method). The CONTAFLEX 49 Spherical Soft (hydrophilic)Contact Lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (hioxifilcon B) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 51% hioxifilcon B and 49% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint. [phthalocvaninato (2-)] copper. The hioxifilcon B name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are: Refractive Index 1.5164 (hydrated) Light Transmission (clear) greater than 96% Light Transmission (tinted) greater than 96% Water Content 49% ± 2% Specific Gravity (wet) 1.140 Oxygen Permeability 16.09 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

The OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Rigid Gas Permeable (RGP) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes, The lenses may be disinfected using a chemical disinfection system only.

OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Daily Wear Contact Lenses.