BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030016 · Supplement: S035 · Decision Mar 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    EVO/EVO+VISIAN Implantable Collamer Lens
    PMA Number
    P030016
    Supplement Number
    S035
    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 25, 2022
    Date Received
    November 1, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    22M-0462

    Advisory Committee Statement

    Approval for the EVO/EVO+ Visian Implantable Collamer Lens. The ICL is indicated for use in patients 21-45 years of age:1. for the correction of myopia with spherical equivalent ranging from -3.0D to less than or equal to-15.0D with less than or equal to 2.5D of astigmatism at the spectacle plane;2. for the reduction of myopia with spherical equivalent ranging from greater than -15.0D to -20.0D with less than or equal to 2.5D of astigmatism at the spectacle plane;3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for 1 year prior to implantation); and4.The ICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.The EVO TICL is indicated for use in patients 21-45 years of age:1. for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D;2. for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane)1.0D to 4.0D;3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 D for both spherical equivalent and cylinder for 1 year prior to implantation); and4. The TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.

    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