VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens

VizionFocus and VizionFocus Color are daily disposable silicone hydrogel soft contact lenses made from mififilcon A material (40% polymer, 60% water). They correct myopia, hyperopia, astigmatism, and presbyopia in non-diseased eyes across spherical, toric, and multifocal designs. The color variant uses FDA-listed colorants to enhance or alter eye appearance, and both variants include UV-blocking technology.

The lenses use mififilcon A (FDA Group V) with 60% water content and oxygen permeability of 80 (×10⁻¹¹). They incorporate a benzotriazole UV-blocking monomer (matching predicate K182247), are cast-molded with injection-molded blister packaging, and use identical handling tints and color additives (including Rutile TiO₂, Iron Oxide, and Phthalocyanine compounds) applied via pad-printing to a 6.0 mm clear pupil diameter.

ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), ISO 10993-23 (acute ocular irritation), ISO 10993-10 (skin sensitization), and ISO 9394 (22-day ocular irritation). Stability, sterility, and package integrity testing was performed over the labeled shelf life. Bench testing included refractive index, water content, oxygen permeability (Dk), light transmission, tensile strength, modulus, and polymerization residuals.

VizionFocus is substantially equivalent to Clariti 1 day (K181920, primary predicate) because both are daily disposable, cast-molded Group V soft hydrophilic contact lenses with identical intended use, indications, and production methods. It is also equivalent to ILICON (K182247, reference predicate) because both use the same benzotriazole UV monomer, manufacturing facility, quality controls, injection-molded packaging, pad-printing color process, and identical handling/color additives. Clinical data from a 120-subject study showed equivalent biomicroscopy, symptoms, adverse reactions, and vision safety compared to Clariti 1 day, with matching non-clinical biocompatibility profiles and performance bench testing.