BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P890023 · Supplement: S011 · Decision Jan 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR
    PMA Number
    P890023
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 16, 2002
    Date Received
    July 20, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE HYDROGENICS 60 (OCUFILCON F) UV IN-MONOMER TINT CONTACT LENS INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATIONS: SPHERICAL: HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM UP TO 2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. TORIC: HYDROGENICS (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO -6.00 DIOPTERS. THE OVERALL POWER RANGE IS +8.00D TO -10.00D SPHERE AND PL TO -6.00D CYLINDER. THE LENS MAY BE PRESCRIBED FOR DAILY OR EXTENDED WEAR IN NOT-APHAKIC PERSONS. WHEN PRESCRIBING FOR EXTENDED WEAR, THE EYE CARE PRACTITIONER MAY RECOMMEND LENS WEAR UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENS FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULES REPLACEMENT. WHEN PRESCRIBING FOR SCHEDULED REPLACEMENT WEAR, THE CONTACT LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) DISINFECTING SYSTEM. HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear