Device Dossier
Soft corrective contact lens, daily-wear
Device Dossier for Soft corrective contact lens, daily-wear (Soft corrective contact lens, daily-wear, Class IIa, sponsor Gelflex Laboratories). ARTG…
- GMDN category: Soft corrective contact lens, daily-wear
Intended purpose
Sofclear (hydrophilic) tinted and Pad Printed Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and /or non-aphakic person with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that; does not interfere with visual acuity. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a frequent replacement, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting system as recommended by the eye care practitioner.