BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N16895 · Supplement: S087 · Decision Mar 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    SOFLENS (POLYMACON) CONTACT LENSES
    PMA Number
    N16895
    Supplement Number
    S087
    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
    March 26, 2001
    Date Received
    November 16, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) THE ESTABLISHMENT OF SEPARATE LABELING FOR THE THERAPEUTIC USE INDICATION; AND, 2) COMBINING THE PACKAGE INSERT AND PROFESSIONAL FITTING GUIDE INTO A SINGLE REFERENCE INTENDED FOR THE EYE CARE PRACTITIONER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T) AND BAUSCH & LOMB OPTIMA(R) FW (POLYMACON) VISIBILITY TINTED CONTACT LENSES. THE LENSES ARE INDICATED FOR USE IN THE TREATMENT AND MANAGEMENT OF ACUTE AND CHRONIC CORNEAL PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL ULCERS AND EROSION, DRY EYES, KERATITIS PROTECTION OF CORNEA DURING AND AFTER SURGERY, ACCIDENTAL OR SURGICAL TRAUMA, AND ENTROPION. WHEN PRESCRIBED FOR THERAPEUTIC USE, THE SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T AND OPTIMA(R) FW) MAY BE WORN FOR DAILY OR EXTENDED WEARING PERIODS. THE EYE CARE PRACTITIONER SHOULD RECOMMEND EITHER SINGLE-USE DISPOSABLE WEAR OR A SCHEDULE OF PERIODIC REPLACEMENT, AND SHOULD PROVIDE INSTRUCTIONS FOR CLEANING, DISINFECTION, AND REPLACEMENT OF THE LENSES. THE LENSES MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. THE LENS SHOULD BE INSERTED AND REMOVED ONLY AS THE EYE CARE PRACTITIONER HAS INSTRUCTED.

    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