BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P890023 · Supplement: S004 · Decision Aug 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES
    PMA Number
    P890023
    Supplement Number
    S004
    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
    August 28, 1996
    Date Received
    October 2, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1)MODIFYING THE MANUFACTURING PROCESS FOR THE OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR LENSES FROM A LOCATOR TINT DIPPING PROCESS AT THE END OF THE MANUFACTURING PROCEDURE TO THE ADDITION OF AN IN-MONOMER TINT INCORPORATING VAT BLUE 6 DYE DURING THE POLYMERIZATION PHASE OF THE MANUFACTURING PROCESS; 2)USING BLISTER PACKAGINAS ALTERNATE PACKAGING MATERIAL; AND 3)ADDING THE FOLLOWING ALTERNATE MANUFACTUIRING SITE FOR LENSES MANUFACTURED BY THE PROCESS DESCRIBED IN ITEM 1: OCULAR SCIENCES/AMERICAN HYDRON, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE S053 4 ND, ENGLAND

    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