BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P040045 · Supplement: S001 · Decision Aug 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL
    PMA Number
    P040045
    Supplement Number
    S001
    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 14, 2007
    Date Received
    April 23, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL INDICATION FOR THERAPEUTIC USE FOR THE VISTAKON (SENOFILCON A) CONTACT LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACUVUE OASYS BRAND CONTACT LENSES WITH HYDRACLEAR PLUS (SENOFILCON A) AND IS ADDITIONALLY INDICATED FOR THERAPEUTIC USE AS A BANDAGE LENS FOR THE FOLLOWING ACUTE AND CHRONIC CONDITIONS:1) FOR CORNEAL PROTECTION IN LID AND CORNEAL ABNORMALITIES SUCH AS ENTROPION, TRICHIASIS, TARSAL SCARS AND RECURRENT CORNEAL EROSION. IN ADDITION IT IS INDICATED FOR PROTECTION WHERE SUTURES OR OCULAR STRUCTURE MALFORMATION, DEGENERATION OR PARALYSIS MAY RESULT IN THE NEED TO PROTECT THE CORNEA FROM EXPOSURE OR REPEATED IRRITATION. 2) FOR CORNEAL PAIN RELIEF IN CONDITIONS SUCH AS BULLOUS KERATOPATHY, EPITHELIAL EROSION AND ABRASION, FILAMENTARY KERATITIS, AND POST-KERATOPLASTY. 3) FOR USE AS A BARRIER DURING THE HEALING PROCESS OF EPITHELIAL DEFECTS SUCH AS CHRONIC EPITHELIAL DEFECTS, CORNEAL ULCER, NEUROTROPHIC AND NEUROPARALYTIC KERATITIS, AND CHEMICAL BURNS. 4) FOR POST SURGICAL CONDITIONS WHERE BANDAGE LENS USE IS INDICATED SUCH AS POST REFRACTIVE SURGERY, LAMELLAR GRAFTS, CORNEAL FLAPS, AND ADDITIONAL OCULAR SURGICAL CONDITIONS. 5) FOR STRUCTURAL STABILITY AND PROTECTION IN PIGGY BACK LENS FITTING WHERE THE CORNEA AND ASSOCIATED SURFACES ARE TOO IRREGULAR TO ALLOW FOR CORNEAL RIGID GAS PERMEABLE (RGP) LENSES TO BE FIT. IN ADDITION THE USE OF THE LENS CAN PREVENT IRRITATION AND ABRASIONS IN CONDITIONS WHERE THERE ARE ELEVATION DIFFERENCES IN THE HOST/GRAPH JUNCTION OR SCAR TISSUE. LENSES PRESCRIBED FOR THERAPEUTIC USE MAY BE WORN FOR DAILY OR EXTENDED WEARING PERIODS.

    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