BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S012 · Decision Sep 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS
    PMA Number
    P930014
    Supplement Number
    S012
    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
    September 2, 2003
    Date Received
    August 5, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PACKAGE INSERT TO CREATE A NEW WARNING BY MOVING AND STRENGTHENING EXISTING TEXT WITHIN THE APPROVED INSERT TO READ AS FOLLOWS: "THE CLINICAL STUDY OF THE ACRYSOF NATURAL SINGLE-PIECE LENS (REFERENCED IN TABLES 2 THROUGH 5) WAS CONDUCTED WITH THE LENS INTENDED FOR IMPLANTATION IN THE CAPSULAR BAG ONLY. THERE IS NO CLINICAL DATA TO DEMONSTRATE ITS SAFETY AND EFFECTIVENESS FOR PLACEMENT IN THE CILIARY SULCUS."

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens