Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted, UV-blocking hydrogel lenses made from Hioxifilcon A material. Available in sphere, asphere, toric, and multifocal designs, they are indicated for daily wear to correct myopia, hyperopia, astigmatism, and presbyopia in persons with non-diseased eyes, with powers ranging from +6.00 to -12.00 diopters. The lenses are single-use disposable.

Both subject and predicate devices use identical Hioxifilcon A material (59% water content, Group II high water non-ionic), refractive index of 1.400, and oxygen permeability of 23.2 × 10⁻¹¹ cm²/sec·mlO₂/ml·mmHg. Both contain UV blockers and are available in sphere, asphere, toric, and multifocal designs. The subject device does not include reduction in transmittance of light (380–450 nm), whereas the predicate does.

Non-clinical testing followed the May 1994 FDA Premarket Notification 510(k) Guidance Document for Class II Contact Lenses. Biocompatibility tests cited ISO 10993-5 (cytotoxicity), ISO 10993-10/ISO 10993-23 (ocular irritation), and ISO 10993-11 (acute systemic toxicity).

The subject device is substantially equivalent because it uses the same USAN material (Hioxifilcon A), identical water content, refractive index, and oxygen permeability as the predicate K232649. Both devices share the same intended use (daily wear correction of refractive error), lens designs (sphere, asphere, toric, multifocal), and UV-blocking capability. The subject device's color additives (Reactive Yellow 15, Reactive Blue 19, Reactive Red 180) are all FDA-approved colorants listed in 21 CFR 73.3121. Non-clinical testing confirms the subject device meets established specifications, remains stable, and is non-toxic and biocompatible, demonstrating safety and effectiveness equivalent to the predicate.