BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Phakic Toric Intraocular Lens

    PMA: P030016 · Supplement: S049 · Decision Dec 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Phakic Toric Intraocular Lens
    Trade Name
    Visian® Toric Implantable Collamer® Lens (TICL)
    PMA Number
    P030016
    Supplement Number
    S049
    Device Class
    FDA Class 3
    Product Code
    QCB
    Generic Name
    Phakic toric intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 10, 2025
    Date Received
    June 26, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to labeling for the Visian® Toric Implantable Collamer Lens (TICL)™, EVO/EVO+ Visian® ICL™, and EVO/EVO+ Visian® TICL™ to reflect the findings of the P030016/S001 PMA New Enrollment Post-Approval Study.

    Classifications

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

    Product Code Device Name
    QCB Phakic Toric Intraocular Lens