BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030028 · Decision Sep 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
    PMA Number
    P030028
    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
    September 10, 2004
    Date Received
    July 1, 2003
    Expedited Review
    Y
    Docket Number
    05M-0026

    Advisory Committee Statement

    APPROVAL FOR THE ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS, ALSO KNOWN AS THE VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS TO BE DISTRIBUTED BY ADVANCE MEDICAL OPTICS. THE DEVICE IS INDICATED FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA IN ADULTS WITH MYOPIA RANGING FROM -5 TO -20 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE AND WHOSE EYES HAVE AN ANTERIOR CHAMBER DEPTH GREATER THAN OR EQUAL TO 3.2 MILLIMETERS; AND, 2) PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 6 MONTHS, AS DEMONSTRATED BY SPHERICAL EQUIVALENT CHANGE OF LESS THAN OR EQUAL TO 0.50 DIOPTERS.

    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