BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030016 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    VISIAN ICL (IMPLANTABLE COLLAMER LENS)
    PMA Number
    P030016
    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
    December 22, 2005
    Date Received
    May 8, 2003
    Expedited Review
    Y
    Docket Number
    06M-0340

    Advisory Committee Statement

    APPROVAL FOR THE VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODELS MICL12.1, MICL12.6, MICL13.2 AND MICL13.7. THE DEVICE IS INDICATED FOR ADULTS 21-45 YEARS OF AGE: 1) TO CORRECT MYOPIA RANGING FROM -3.0 DIOPTERS TO <=-15.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) TO REDUCE MYOPIA RANGING FROM GREATER THAN -15.0 DIOPTERS TO -20.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; AND 3) WITH AN ANTERIOR CHAMBER DEPTH (ACD) 3.00 MM OR GREATER, AND A STABLE REFRACTIVE HISTORY WITHIN 0.5 DIOPTER FOR 1 YEAR PRIOR TO IMPLANTATION.

    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