BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P080011 · Decision Nov 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    BIOFINITY (COMFILCON A)
    PMA Number
    P080011
    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
    November 19, 2008
    Date Received
    April 7, 2008
    Expedited Review
    N
    Docket Number
    08M-0608

    Advisory Committee Statement

    APPROVAL FOR THEBIOFINITY (COMFILCON A) SOFT CONTACT LENS. THIS DEVICE IS INDICATED FOR USE AS FOLLOWS:BIOFINITY (COMFILCON A) SPHERE AND ASPHERC SOFT CONTACT LENSES ARE INDICATED FOR THECORRECTION OF AMETROPIA (MYOPIA AND 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 WITHVISUAL ACUITY.BIOFINITY (COMFILCON A) TORIC SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OFAMETROPIA (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.BIOFINITY (COMFILCON A) MULTIFOCAL SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND EMMETROPIA WITH PRESBYOPIA INAPHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS WITH ADD POWERS FROM +0.50 TO +3.00 DIOPTERS. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.BIOFINITY (COMFILCON A) CONTACT LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR UP TO 6 NIGHTS AND 7 DAYS OF CONTINUOUS WEAR. IT IS RECOMMENDED THAT THE CONTACT LENS WEARER BE FIRST EVALUATED ON A DAILY WEAR SCHEDULE PRIOR TO OVERNIGHT WEAR. THE LENSES MAY BEPRESCRIBED FOR EITHER ONE WEEK DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WITH CLEANING,DISINFECTION AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT, THELENSES MUST BE CLEANED AND DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY.

    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