BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P190018 · Supplement: S013 · Decision Jan 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Extended Depth Of Focus Intraocular Lens
    Trade Name
    Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO
    PMA Number
    P190018
    Supplement Number
    S013
    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
    January 26, 2022
    Date Received
    October 29, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Clareon Vivity Extended Vision Hydrophobic IOL and the Clareon Vivity Toric Extended Vision Hydrophobic IOL in lens case and AutonoMe Automated Pre-loaded Delivery System configurations.

    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