Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)

Deseyne (vifilcon C) is a daily disposable soft contact lens made of hydrophilic material designed to correct refractive errors (myopia and hyperopia) in presbyopic patients. The lens includes an Extended Depth of Focus (EDOF) feature with a central 1.0 mm dome-shaped zone to mitigate presbyopia effects, and it contains UV-blocking components and hyaluronic acid in the packaging solution.

The subject device differs from the predicate device (K240918) by adding a presbyopic lens design with a 0.5 mm central zone radius and 8.0D power difference; the predicate has no central zone. Both use the same vifilcon C material, 60% water content, 1.403 refractive index, and 27.5×10⁻¹¹ oxygen permeability. The subject device center thickness is 0.07 mm versus 0.05 mm for the predicate.

ISO 18369-2:2006 (tolerances), ISO 18369-3:2006 (measurement methods), and ISO 18369-4:2006 (physicochemical properties). Biocompatibility testing was not required per FDA's 2023 Biocompatibility Guidance referencing ISO 10993-1.

Both devices are daily disposable soft contact lenses made of vifilcon C with identical material properties, water content, and refractive index, and both correct myopia and hyperopia in the same FDA classification group (Group IV, high water, ionic). The principal difference—the presbyopic EDOF design—does not raise different safety or effectiveness questions, and clinical testing demonstrated statistically significant improvement in depth of focus (0.78D increase) with no adverse events reported.