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The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear 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 (e.g., LASIK) surgery. The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable 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 lens may concurrently provide correction of refractive error. The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorber. The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters: | Parameter | Range | Tolerance | |--------------------|--------------------|------------------------------------------------------------------------------------------------------------------| | Base Curve | 4.00mm to 11.50mm | ± 0.05 mm | | Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm | | Diameter | 7.0mm to 21.0mm | ± 0.10mm | | Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D) | | Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D) | | Multifocal Power | +1.00D to 4.00D | ± 0.25D | | Surface Appearance | | Lenses should be clear with no surface<br>defect | The following table depicts the physical properties of the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses: | | Fluoroxyfocon A Rigid Gas Permeable Contact Lens | | |-----------------------------|--------------------------------------------------------------------------------|--| | Refractive Index | 1.430 | | | Modulus (MPa) | 1194 | | | Hardness (Shore D) | 78 | | | Specific Gravity | 1.18 | | | Oxygen Permeability<br>(Dk) | 200 x 10 to the power of -11 (cm squared/sec) (ml O2/ml x mm Hg @ 35 degrees C) | | | Color Additives | Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17 | | The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are supplied dry (without storage solution) and non-sterile in a screw top case and must be cleaned and conditioned prior to use.