BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P210005 · Supplement: S005 · Decision Jul 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Extended Depth Of Focus Intraocular Lens
    Trade Name
    IC-8 Apthera Intraocular Lens
    PMA Number
    P210005
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    POE
    Generic Name
    Extended depth of focus intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 31, 2023
    Date Received
    June 1, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Bausch & Lomb, 21 N. Park Place Blvd., Clearwater, Florida, 33759 for the following functions: 1) Receiving inspections of device raw materials/ subassemblies 2) Shipping and handling of device raw materials/subassemblies 3) Lot release and documentation review of finished devices 4) Handling, storage, preservation and distribution of finished devices.

    Classifications

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

    Product Code Device Name
    POE Extended Depth Of Focus Intraocular Lens