BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P850079 · Supplement: S047 · Decision May 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR
    PMA Number
    P850079
    Supplement Number
    S047
    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
    May 3, 2010
    Date Received
    December 28, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRADE NAME CLEAR SOFT. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME CLEAR SOFT AND IS INDICATED FOR:CLEAR SOFT SPHERE (METHAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA OR HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BYPERSONS WHO EXHIBIT ASTIGMATISM OF -2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.CLEAR SOFT TORIC (METHAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTIONOF AMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONSWITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS AND ASTIGMATICCORRECTIONS FROM -0.25 TO -5.00 DIOPTERS.THE CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HAVE BEEN APPROVED FOR EXTENDED WEAR FOR UP TO 6 NIGHTS/7 DAYS OF CONTINUOUS WEAR. IT ISRECOMMENDED THAT THE CONTACT LENS WEARER FIRST BE EVALUATED ON A DAILY WEAR SCHEDULE. IFSUCCESSFUL, THEN A GRADUAL INTRODUCTION OF EXTENDED WEAR CAN BE FOLLOWED AS DETERMINED BY THE PRESCRIBING EYE CARE PRACTITIONER.EYE CARE PRACTITIONERS MAY PRESCRIBE THE LENS FOR FREQUENT REPLACEMENT WEAR WITH CLEANING, DISINFECTING AND SCHEDULED REPLACEMENTS.

    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