Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

The Saview SH Optic 38 UV is a soft (hydrophilic) silicone hydrogel contact lens made from senofilcon A material with UV-absorbing properties and blue visibility tint. It is indicated for daily wear to correct refractive errors (myopia, hyperopia, and astigmatism) in patients with non-diseased eyes, available in spherical, toric, and multifocal designs. The device is for frequent replacement wear using chemical disinfection systems.

The subject device is identical to the predicate (K250364) in material composition, water content (38%), oxygen permeability, UV transmittance (UVB <5%, UVA <50%), visible light transmittance (≥90%), refractive index (1.42), and packaging. The primary difference is the change from daily disposable wear modality to frequent replacement wear modality with the same lens specifications and care requirements.

Testing followed ISO 11981:2017, ISO 18369 series (parts 1-4, 2017), ISO 10993 series for biocompatibility (cytotoxicity, ocular irritation, systemic injection), ISO 17665-1:2006 for sterilization, ISO 11737 series for sterility validation, USP chapters 71, 61, and 87, and FDA guidance documents for color additives in contact lenses.