BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P190018 · Supplement: S009 · Decision Mar 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph
    PMA Number
    P190018
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 15, 2021
    Date Received
    December 14, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to expand dioptric-power range to 6.0 D - 34.0 D for Clareon PanOptix Trifocal Hydrophobic IOL (CNWTT0), Clareon PanOptix Trifocal UV Absorbing IOL (CCWTT0), and Clareon PanOptix Trifocal Hydrophobic IOL models CNWTT3-CNWTT6, as well as approval for Clareon PanOptix Toric Trifocal Hydrophobic IOL with the AutonoMe Automated Preloaded Delivery Device (CNATT3-CNATT6).

    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