BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030016 · Supplement: S051 · Decision Mar 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    The EVO/EVO+ Visian Implantable Collamer Lens (ICL)
    PMA Number
    P030016
    Supplement Number
    S051
    Device Class
    FDA Class 3
    Product Code
    MTA
    Generic Name
    Lens, intraocular, phakic
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 4, 2026
    Date Received
    September 15, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a software update to the optical metrology system used in the production of EVO/EVO+ Visian and Visian Toric Implantable Collamer® Lenses to incorporate lens size and lens model identification inspection capabilities, in addition to the existing dioptric power and image quality measurement functions.

    Classifications

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

    Product Code Device Name
    MTA Lens, Intraocular, Phakic