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

    Lens, Multifocal Intraocular

    PMA: P240005 · Supplement: S002 · Decision Dec 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
    PMA Number
    P240005
    Supplement Number
    S002
    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
    December 11, 2024
    Date Received
    November 15, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to remove the ‘deflash polish operations’ utilized in the current enVista Envy IOL manufacturing process

    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