BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P980006 · Supplement: S007 · Decision May 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE
    PMA Number
    P980006
    Supplement Number
    S007
    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
    May 27, 2005
    Date Received
    March 3, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING A THERAPEUTIC INDICATION FOR THE PUREVISION CONTACT LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS FOR THERAPEUTIC USE AND IS INDICATED FOR THERAPEUTIC USE AS A BANDAGE CONTACT LENS FOR CORNEAL PROTECTION AND CORNEAL PAIN RELIEF DURING TREATMENT OF OCULAR PATHOLOGIES AS WELL AS POST-SURGICAL CONDITIONS. APPLICATIONS OF THE PUREVISION CONTACT LENS INCLUDE BUT ARE NOT LIMITED TO CONDITIONS SUCH AS THE FOLLOWING: 1) FOR CORNEAL PROTECTION IN CONDITIONS SUCH AS ENTROPION, TRICHIASIS, TARSAL SCARS, RECURRENT CORNEAL EROSION AND POST SURGICAL PTOSIS FOR CORNEAL PROTECTION; 2) FOR CORNEAL PAIN RELIEF IN CONDITIONS SUCH AS BULLOUS KERATOPATHY, EPITHELIAL EROSION AND ABRASION, FILAMENTARY KERATITIS, POST-KERATOPLASTY; 3) FOR USE AS A BANDAGE DURING THE HEALING PROCESS OF CONDITIONS SUCH AS CHRONIC EPITHELIAL DEFECTS, CORNEAL ULCER, NEUROTROPHIC KERATITIS, NEUROPARALYTIC KERATITIS, CHEMICAL BURNS, AND POST SURGICAL EPITHELIAL DEFECTS; AND 4) FOR POST SURGICAL CONDITIONS THAT INCLUDE BANDAGE USE SUCH AS LASIK, PRK, PK, PTK, LAMELLAR GRAFTS, CORNEAL FLAPS, AND ADDITIONAL CORNEAL SURGICAL CONDITIONS. PURE VISION CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE CORRECTION DURING HEALING IF REQUIRED.

    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