VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens

The VizionFocus (somofilcon A) Silicone Hydrogel Soft Contact Lens is a monthly disposable contact lens made from somofilcon A material for correcting myopia and hyperopia. Available in spherical, aspheric, toric, and multifocal designs, it is indicated for daily wear with chemical disinfection, correcting refractive errors in powers from -20.00 to +20.00 diopters with optional astigmatism and presbyopia correction.

The device is composed of 44% somofilcon A polymer and 56% water, with an oxygen permeability of 60 × 10⁻¹¹, water content of 56%, and refractive index of 1.398. It incorporates a benzotriazole UV-blocking monomer (same as predicate K242413) and phthalocyanine blue handling tint. Manufacturing uses cast-molding in injection-molded polypropylene blister packaging, identical to the reference predicate device.

ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), and ISO 10993-23 (acute ocular irritation) biocompatibility testing were conducted under Good Laboratory Practice regulations. Bench testing included refractive index, water content, oxygen permeability (Dk), visible and UV light transmittance, tensile strength, modulus, and elongation to break measurements.

The device uses identical somofilcon A material, manufacturing method, packaging materials, and UV-blocking monomer as the reference predicate (K242413), with the same lens designs and indications for use. Non-clinical performance testing demonstrates consistent physicochemical and mechanical properties between the subject device and predicates. Since somofilcon A soft contact lens clinical performance has been previously established, clinical testing is not required. The risks and benefits are equivalent to other soft hydrophilic daily wear contact lenses.