BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P990072 · Decision Aug 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
    PMA Number
    P990072
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    August 22, 2000
    Date Received
    November 16, 1999
    Expedited Review
    N
    Docket Number
    00M-1475

    Advisory Committee Statement

    APPROVAL FOR THE HORIZON 55 EW AND HORIZON 55 EW WESTINT (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND VISIBILITY TINT). THESE DEVICES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVEL FOR CLEANING, RINSING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 1.50 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.

    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