Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)

Aurora (ocufilcon D) is a soft daily-wear contact lens made from a hydrophilic copolymer that corrects refractive errors (myopia, hyperopia) and presbyopia. Available in spherical, toric, and multifocal designs, the lenses are tinted for visibility and can enhance or alter eye color using FDA-listed color additives. They contain UV-absorbing monomers and are suitable for frequent/planned replacement wear or single-use daily disposable wear.

The Aurora uses the same ocufilcon D material (45% polymer, 55% water) as the predicate ILICON device, with identical water content (55±2%), oxygen permeability (19.6×10⁻¹¹), refractive index (1.410), and modulus (0.49 MPa). Both are fully molded, FDA Group 4 soft hydrophilic lenses with UV blockers and pad-printed tinting. The primary difference is the tinting color: Aurora uses light yellow-green versus the predicate's blue color, and both maintain a 6.0 mm clear pupil diameter.

Toxicology testing followed ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), and ISO 10993-23 (ocular irritation). Physicochemical and mechanical properties were tested per ANSI Z80.20 (ophthalmics—contact lenses—standard terminology, tolerances, measurements, and physicochemical properties, 2010). All non-clinical studies were conducted under Good Laboratory Practice regulations per 21 CFR 860.7.

Aurora is substantially equivalent to the predicate ILICON because both are made from identical ocufilcon D material, share all critical material properties (water content, oxygen permeability, refractive index, modulus), use the same manufacturing process (fully molded), and have identical intended uses (daily-wear correction of refractive errors in spherical, toric, and multifocal designs). The only difference—the color tint used in pad-printing—does not affect safety or effectiveness; preclinical toxicology, shelf-life, and physicochemical testing confirmed non-toxicity and material consistency. Since the lens specifications, performance characteristics, and design configurations are equivalent to a lawfully marketed predicate, the device presents no new safety or efficacy risks.