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510(k) Data Aggregation
(111 days)
Sphere and Asphere:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the spherical and aspheric design are indicated for monthly disposable wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the toric design is indicated for monthly disposable wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
Multifocal:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the multifocal design is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is a hemispherical shell with a molded base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lens is fabricated from somofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 44.0% somofilcon A and 56.0% water by weight when immersed in saline solution. The somofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (316nm - 380nm).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is manufactured in spherical/aspheric, toric, multifocal design configurations. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.050 mm to 0.200 mm | When ≤ 0.10 mm ±0.010 mm + 10% When > 0.10 mm ±0.015 mm + 5% |
| Base Curve | 7.0 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | -20.00 D to +20.00 D (in 0.25 D steps) | When 0.00 < |
| Cylinder Power (F'c) | -0.25 D to -2.25 D (in 0.25 D steps) | When 0.00 < F'c ≤ 2.00 D ±0.25 D When 2.00 < F'c ≤4.00 D±0.37 D |
| Cylinder Axis | 10° to 180° in 10° steps (in 10° steps) | When 0.00 < F'c ≤ 1.50 D ± 8° When F'c > 1.50 D± 5° |
| Multifocal Power | +0.25 D to +4.00 D (in 0.25 D steps) | ±0.25D |
| Oxygen Permeability (x 10-11 (cm2•ml O2)/(sec•ml•mmHg)) | 60 | ±20% |
| Visible Light Transmittance | >95% | ±5% |
| Ultraviolet radiation Transmittance | < 5% TUVB <20% TUVA | TUVB (280 to 315nm) < 0.05 TV TUVA (316 to 380nm) < 0.05 TV |
| Water Content | 56% | ±2% |
| Refractive Index | 1.398 | ±0.005 |
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