BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P190018 · Supplement: S047 · Decision Feb 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic
    PMA Number
    P190018
    Supplement Number
    S047
    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
    February 19, 2026
    Date Received
    November 21, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon TruPlus Toric Aspheric Hydrophobic Acrylic IOL, Clareon TruPlus Aspheric UV Absorbing IOL, and Clareon TruPlus Toric Aspheric UV Absorbing IOL in both lens case and AutonoMe 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
    HQL Intraocular Lens