BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S087 · Decision Dec 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF INTRAOCULAR LENS
    PMA Number
    P930014
    Supplement Number
    S087
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 31, 2015
    Date Received
    December 7, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALCON LABORATORIES IRELAND LTD. AS AN ALTERNATE INTRAOCULAR LENS MANUFACTURING FACILITY FOR ACRYSOF IQ TORIC IOL (MODELS SN6AT6, SN6AT7, SN6AT8, SN6AT9) AND THE USE OF THE MANUAL WET NIMO EQUIPMENT FOR THE SPHERICAL ABERRATION MEASUREMENT MANUFACTURING PROCESS STEP IN PLACE OF THE CURRENT LONG WET MANUAL ABERROMETER SYSTEM SPECIFICALLY FOR LOW DIOPTER (6.0 ¿ 9.5 DIOPTER) IQ TORIC LENSES.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens