BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORCHER

    MDR report key: 505869 · Received January 1, 2004

    Report

    Report Number
    MW1030733
    Event Type
    Injury
    Date Received
    January 1, 2004
    Date of Event
    August 25, 2003
    Report Date
    January 1, 2004
    Manufacturer
    MORCHER GMBH STUTTGART
    Product Code
    MRJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CATARACT SURGERY WITH PLANNED PIGGYBACK IOL'S IN HIGH HYPEROPE, SMALL EYE, AND TIGHT LID FISSURES. UNPLANNED EMERGENCY USE OF CAPSULAR TENSION RING INTRAOPERATIVELY DUE TO ZONULAR DEHISCENCE. POSTOPERATIVE SLOW HEALING WITH INCREASED INFLAMMATION. ENDOPHTHALMITIS PRESUMPTIVELY DIAGNOSED 3 WEEKS LATER, WORKED UP, AND TREATED WITH INTRAVITREAL ANTIBIOTIC INJECTIONS. PT IMPROVED AND UNCORRECTED VISION 2 MONTHS LATER WAS 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORCHER CAPSULAR TENSION RING MRJ MORCHER GMBH STUTTGART TYPE 14 ADFBAA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IN 2003 IOL IMPLANTS: ALLERGAN AR40E.