BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S092 · Decision Oct 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0
    PMA Number
    P930014
    Supplement Number
    S092
    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
    October 12, 2016
    Date Received
    July 20, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to your real time shelf life protocol to substitute the aerosol microbial challenge test with the microbial barrier test and to add a seal strength test for your AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-Loaded Delivery System, Model AU00T0.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens