BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P190018 · Supplement: S001 · Decision Jul 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Clareon and Clareon Toric Intraocular Lenses (IOLs)
    PMA Number
    P190018
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 15, 2020
    Date Received
    April 16, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 3 changes related to the shelf life of the Clareon IOLs: 1) 3 year shelf life labeling for the Clareon and Clareon Toric IOLs presented in the AutonoMe Pre-Loaded Delivery System (Models CNAOTO and CNAOT3-CNAOT9); 2) a revision of the labeled storage condition to 15-30 °C for the Clareon and Clareon Toric IOLs presented in the AutonoMe Pre-Loaded Delivery System (Models CNAOTO and CNAOT3-CNAOT9); and 3) a revision to the ongoing real-time shelf life study protocols to streamline planned testing.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens