Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

Pegavision (Toufilcon B) contact lenses are soft hydrophilic lenses available in daily disposable and frequent replacement formats. They correct refractive errors (myopia, hyperopia, astigmatism, presbyopia) in spherical, aspherical, toric, and multifocal designs for daily wear in non-diseased eyes.

The subject device uses identical lens material (Toufilcon B), water content (50%±2%), oxygen permeability (91×10⁻¹¹ cm²/s), refractive index (1.405), sterilization method (moist heat), and power ranges as the predicate. The only difference is the packaging solution formulation: subject device includes two variants with or without Cyanocobalamin, whereas the predicate contains only Sodium Hyaluronate.

ISO 18369-3 and ISO 18369-4 for optical and physical properties; ISO 11987 for shelf life and sterility; ISO 10993 series (parts 5, 10, 11, 23) for biocompatibility including cytotoxicity, ocular irritation, skin sensitization, and acute systemic toxicity testing.

The technological characteristics—lens design, material, water content, oxygen permeability, and sterilization—are identical to predicate K243868. The sole difference in packaging solution composition was evaluated through biocompatibility testing, which confirmed no adverse effects on safety or performance, demonstrating substantial equivalence.