BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ring, Endocapsular

    PMA: P010059 · Supplement: S003 · Decision May 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Ring, Endocapsular
    Trade Name
    MORCHER CAPSULAR TENSION RINGS
    PMA Number
    P010059
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MRJ
    Generic Name
    Ring, endocapsular
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 22, 2009
    Date Received
    March 19, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF CAPSULAR TENSION RINGS (CTRS) MODELS1G, 2S, 6D, 6E, AND 10C AND CHANGE IN PACKAGING TO INCORPORATE THE MORCHER INJECTOR PRELOADED WITH CTR MODELS 14, 14A, AND 14C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MORCHER CAPSULAR TENSION RINGS (MODELS 1G, 2S, 6D, 6E, AND 10C) AND EYEJET CTR AND IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK ORPARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENSIMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARYZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA ORVITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI¿S SYNDROME.

    Classifications

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

    Product Code Device Name
    MRJ Ring, Endocapsular