BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON ACS BIOSORB SUTURE 6-0

    MDR report key: 807261 · Received January 19, 2007

    Report

    Report Number
    MW1041674
    Event Type
    Other
    Date Received
    January 19, 2007
    Date of Event
    December 1, 2006
    Report Date
    January 19, 2007
    Manufacturer
    ALCON LABORATORIES
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALCON ACS BIOSORB SUTURE SIZE 6-0 ITEM NUMBER 10380658631014, LOT NUMBER E4J082. I HAVE USED THIS SUTURE SINCE IT CAME ON THE MARKET -7 YRS- . IN THE PAST FEW WEEKS SINCE OPENING A NEW BOX I HAVE HAD MULTIPLE PTS WITH INTRAOPERATIVE EVIDENCE OF THE SUTURE STRETCHING, CAUSING MULTIPLE RE-TIES. IN THIS PARTICULAR PT I PERFORMED BILATERAL LATERAL RECTUS RESECTIONS AND HAD TROUBLE WITH BOTH SIDES. ON POST-OPERATIVE CLINICAL EXAMINATION IT IS EVIDENT THAT THE LEFT LATERAL RECTUS HAS SLIPPED BACK FROM ITS SUTURED LOCATION FAR ENOUGH TO CAUSE LIMITATION OF MUSCLE FUNCTION AND THIS WILL REQUIRE REPEAT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON ACS BIOSORB SUTURE 6-0 * GAR ALCON LABORATORIES * E4J0382

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other