P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

P-CON is a soft hydrophilic contact lens made from polymacon (38% water, 62% polymer) for daily wear correction of myopia (-0.00 to -10.00 diopters) in non-diseased eyes. The lenses are available clear or tinted with pad-printed color patterns to enhance eye appearance, and are prescribed for quarterly replacement with chemical disinfection.

Both subject and predicate devices use polymacon material (HEMA crosslinked with EGDMA) in FDA Group 1 classification, fully molded production method, 38±2% water content, similar oxygen permeability (9.40±20% vs 10.26±20%), identical refractive index (1.437-1.438±0.005), pad-printed tinting, and steam sterilization in blister pack with aluminum foil seal. Key difference: subject is spherical; predicate is aspheric.

ISO 10993 series (cytotoxicity, sensitization, acute ocular irritation, acute systemic toxicity, pyrogenicity); ISO 9394 (contact lens biocompatibility in rabbit eyes); 21 CFR standards for soft hydrophilic contact lenses; physicochemical and mechanical properties testing per standard specifications.

Both devices correct visual acuity in non-aphakic persons with myopia using identical polymacon material, manufacturing method (full molding), water content, and sterilization. Although the predicate is aspheric and corrects hyperopia/presbyopia while the subject is spherical for myopia only, the fundamental intended use—correcting refractive error with equivalent biocompatibility and mechanical properties—is the same. Oxygen permeability and all measured properties fall within FDA performance criteria, making functional safety and effectiveness equivalent despite design differences.