BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P990018 · Supplement: S002 · Decision Jul 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Rigid Gas Permeable), Extended Wear
    Trade Name
    MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
    PMA Number
    P990018
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MWL
    Generic Name
    Lens, contact (rigid gas permeable), extended wear
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 12, 2002
    Date Received
    November 28, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    02M-0335

    Advisory Committee Statement

    APPROVAL FOR THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS. THIS DEVICE IS INDICATED FOR: MENICON Z (TISILFOCON A) SPHERICAL, ASPHERIC, NON-PRISM BALLAST TORIC AND NON-PRISM BALLAST MULTIFOCAL LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 30 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PROFESSIONAL) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS MAY BE PRESCRIBED IN SPHERICAL AND ASPHERIC POWERS RANGING FROM -25.00 D TO +25.00 D FOR DAILY WEAR AND -25.00 D TO +8.00 D FOR UP TO 30 DAYS EXTENDED WEAR. TORIC LENSES ARE DESIGNED TO CORRECT UP TO 5.00 D OF ASTIGMATISM AND MULTIFOCAL LENSES TO PROVIDE UP TO +3.00 D OF READING ADD POWER FOR UP TO 30 DAYS EXTENDED WEAR. THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY. (THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS WAS CLEARED FOR DAILY WEAR UNDER K962006, K970019 AND K972443).

    Classifications

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

    Product Code Device Name
    MWL Lens, Contact (Rigid Gas Permeable), Extended Wear