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

    Lens, Multifocal Intraocular

    PMA: P040020 · Supplement: S096 · Decision Oct 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
    PMA Number
    P040020
    Supplement Number
    S096
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 2, 2020
    Date Received
    September 10, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adding an alternate supplier for the blue tinted fiber strands which the Alcon Huntington (Alcon HWV) manufacturing site will further process into individual haptics for AcrySof® and AcrySof® ReSTOR® multi-piece intraocular lenses (IOLs).

    Classifications

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

    Product Code Device Name
    MFK Lens, Multifocal Intraocular