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The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.

The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.

FluoroPerm® 92 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, FluoroPerm® 92 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. FluoroPerm® 60 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, FluoroPerm® 60 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. Paragon HDS® rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® toric contact lenses with Tangible Hvdra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon HDS® contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. FluoroPerm® 30 rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses with Tanzible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, FluoroPerm® 30 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. Paragon Thin rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. Paragon Thin rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin'm toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon Thin™ contact lenses with Tangible Hydra-PEG are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eves. FluoroPerm® 151 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, FluoroPerm® 151 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon HDS® 100 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 lenses with Tangible™ Hydra-PEG are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the following currently marketed contact lens materials: paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30. Paragon Thin™), paflufocon D (FluoroPerm® 151, Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber (not in all colors and materials). The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve. The FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin™ FluoroPerm®151, and Paragon HDS® 100 lenses are 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 is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

FluoroPerm® 92 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only. FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only. FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. FluoroPerm® 60 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 60 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 dionters that does not interfere with visual acuity. FluoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only. FluoroPerm® 60 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Paragon HDS® rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon HDS® contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, FluoroPerm® 30 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. Paragon Thin™ rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. Paragon Thin" rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon Thin" contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. FluoroPerm® 151 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 151 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, FluoroPerm® 151 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. Paragon HDS® 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only. Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon HDS® 100 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 30, Paragon Thin™, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; patlufocon A (FluoroPerm®92), patlufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30, Paragon Thin"), and paflufocon D (FluoroPerm® 151, Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lens. The lenses may be available with an ultraviolet absorber (not in all colors and materials). The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve. FluoroPerm® 92, FluoroPerm® 60, FluoroPerm® 151, Paragon HDS®, and Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92. FluoroPerm® 60, FluoroPerm® 151, Paragon HDS® 100 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only. FluoroPerm® 30 and Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes. . The safety and effectiveness of paflufocon A (FluoroPerm® 92), patlufocon B (FluoroPerm® 60 and Paragon HDS®), paflufocon C (FluoroPerm® 30 and Paragon Thin") and paflufocon D (FluoroPerm® 151 and Paragon HDS® 100) materials as rigid gas permeable contact lenses have been demonstrated in PMA P870024 and several of its supplements.

HDS HI 1.54™ rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. HDS HI 1.54™ rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of refractive ametropia in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. HDS HI 1.54™ toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. HDS HI 1.54™ bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. HDS HI 1.54™ contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery, in otherwise non-diseased eyes.

HDS HI 1.54 (pahrifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior, or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The HDS HI 1.54 rigid gas permeable contact lens material is a thermoset copolymer derived from acrylate, silicone acrylate, and fluorosilicone acrylate monomers, dimers and oligomers. The HDS HI 1.54 rigid gas permeable tinted lenses offer a handling aid for locating the lens and may be plasma treated.

FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I horor chil. 92 ngla ga permission between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphabic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal leases are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as kerator ones, pellucid marginal degeneration, or following penctrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I tobior and out from 1 to 7 days between removals for cleaning and disinfection as recommonded by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact leases are indicated for daily wear only. FluoroPerm® 60 rigid gas permeable spheric and bifocal contact leases are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfece with visual acuity. FivoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm® 60 contact leases are indicated for management of irregular comcal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoriasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the cye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Paragon HDS rigid gas permeable spherical, asphenc and bifocal contact lenses are indicated for the correction of visual aculty in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS tone contact leases are indicated to correct astigmatism of up to 6.00 diopters. Faragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. Paragon HDS contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratotorny, radial keratotorny, or LASIK surgeryin otherwise nondiseased eyes. FluoroPerm® 30 rigid gas permeable contact leases are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm* 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up 10 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up 10 6.00 diopters. FluoroPerm* 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm® 30 contact lenses are indicated for management of irregular comeal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. Paragon Thin " rigid gas permeable contact lenses are indicated for daily wear as recommended by the eve care practitioner. Paragon Thin rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased tyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comes astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" witc contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin bifocal lenses are indicated to treat presbyopia up 10 +4.00 D add power. Paragon Thin" contact lenses are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerme 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm 151 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased cycs that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPenn® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopers. FluoroPerm 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm 151 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes. Paragon HDS 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Paragon HDS 100 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual scuity in not-aphakic persons with nondiseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diovers that docs not interfere with visual acuity. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. Paragon HDS 100 contact leases are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following peactrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 92, FluoroPerm® 60, Paragon HDS*, FluoroPerm* 30, Paragon Thin"*, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; pastufocon A (FluoroPerm" 02), pallufocon B (FluoroPerm) 60, Paragon HDS®), patlufocon C (Fluorosco (Film The Paragon Time), and Poly San Poly San Parised Bron fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling and for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17. The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber, Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2.2'-dihydroxy-4,4'-dimethoxybenzophenone. The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspherical curves peripheral to the base curve.

FluoroPerm® 92 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permicable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D ad power. FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 contact lenses are indicated for persons requiring. keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Paragon HDS® rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. Paragon Thin" rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin"" bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 151 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. F FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. Paragon HDS® 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiscased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Keratoconus contact lens designs are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30, Paragon Thin""), and paflufocon D (FluoroPerm® 151. Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17. These products may be plasma treated. The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber. Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2,2'-dihydroxy-4,4'dimethoxybenzophenone. The lens designs have a posterior surface consisting of a base curve and a series of four spherical or aspherical curves progressively flatter than the base curve.

The PVS Basic™2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic" 2 (migafocon A) and Epic 2 (migafocon A) bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted), including astigmatic corrections up to + 4.00 D requiring add power of up to + 4.00 D.

The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are available in blue. The blue tinted lenses contain D&C Green # 6. The lenses have the following dimensions and characteristics: Material: migafocon A, Indication: Daily Wear, Water Content: < 1%, Oxygen Permeability*: 74 x 10-11 Dk at 35° C., Oxygen Permeability**: 52 x 10-11 Dk at 35° C, Luminous Transmittance (blue) ***: 87%, Wetting Angle (receding angle)****: 16, Hardness (Shore D): 82.6, Refractive Index*****: 1.454 (nD at 25° C), Specific Gravity: 1.10, Color: Blue. Lens Parameters: Chord Diameter: 7.0 to 10.5 mm, Center Thickness: 0.05 to 0.70 mm, Base Curve: 6.50 to 9.00 mm, Power: -20.00 to +12.00 Diopters, Bifocal Add Power: + 0.25 to +4.00 Diopters, Concentric Bifocal Add Diameter: 2.0 to 4.0 mm, Monocentric Bifocal Add Diameter: 4.0 to 9.0 mm, Monocentric Bifocal Prism: 0 to 2.5 Diopters.

The SportSight GP (paflufocon C) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The SportSight GP (paflufocon C) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. SportSight GP (paflufocon C) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. SportSight GP bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D. SportSight GP (paflufocon C) contact lenses are indicated for the attenuation of bright light and the reduction of glare. SportSight TM GP (paflufocon C) contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The SportSight GP (paflufocon C) intensely tinted, rigid gas permeable contact lenses are available in SportSight Gray. The Gray tinted lens contains D&C Red # 17, D & C Green No. 6, and Perox Yellow No. 9. The lenses have the following dimensions: Refractive Index 1.466(Nd at 25°C), Luminous Transmittance (driving allowed) 8% - 26%, Luminous Transmittance (driving prohibited) 1% - 8%, Wetting Angle (Receding Angle) 12.81 1.14, Specific Gravity, Hardness (Shore D) 84, <1% Water Content, Oxygen Permeability 30 x 1 0-1 1 Dk* at 35°C *(cm³/sec)(mL 02/mL x mm Hg) Revised method of Irving Fatt, Ph.D. ** harmonic mean transmission over 4mm. Lens Parameters: Chord Diameter 7.0 to 14.5 mm, Center Thickness (driving allowed) 0.09 - 0.275 mm, Center Thickness (driving prohibited) 0.275- 0.475 mm, Base Curve 6.50 to 9.00 mm, Powers -20.00 to +12.00 Diopters, Bifocal Add Powers +0.25 to + 4.00 Diopters, Concentric Bifocal Add Diameter 2.0 to 4.0 mm, Monocentric Bifocal Add Diameter 4.0 to 9.0 mm, Monocentric Bifocal Prism 1.0 to 2.5 Diopters.