BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P910056 · Supplement: S010 · Decision May 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60
    PMA Number
    P910056
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 30, 2012
    Date Received
    September 12, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MATERIAL CHANGE AND DESIGN MODIFICATIONS (3-PIECE TO 1-PIECE DESIGN AND ASPHERIC SURFACE) TO THE APPROVED BAUSCH & LOMB SILICONE LENS C31UB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENVISTA ONE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENS, MODEL MX60 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM THE CATARACTOUS CRYSTALLINE LENS HAS BEEN REMOVED.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQL Intraocular Lens