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

    Intraocular Lens

    PMA: P190018 · Supplement: S019 · Decision May 3, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher
    PMA Number
    P190018
    Supplement Number
    S019
    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
    May 3, 2022
    Date Received
    April 6, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Transfer of the nozzle coating process during manufacturing of the AutonoMe Automated Pre-loaded Delivery System from Alcon Huntington, West Virginia to Alcon Laboratories, Ireland.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens