BEUDAMED
    FDA Adverse Event Other Summary report: N

    MST 19 GAUGE PACKER/CHANG IOL CUTTERS

    MDR report key: 2050928 · Received April 1, 2011

    Report

    Report Number
    3019924-2011-00002
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    November 2, 2010
    Report Date
    March 23, 2011
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(6) SENTINEL NETWORK REPORT WAS RECEIVED INDICATING THAT A MST IOL SCISSOR HAD BROKEN IN A PT'S EYE WHILE ATTEMPTING TO CUT A HARD PMMA IOL CONTRARY TO THE INTENDED USE OF THE DEVICE. WHILE THERE WAS NO DAMAGE IN THIS INSTANCE TO THE PT, RECURRENCE COULD RESULT IN DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST 19 GAUGE PACKER/CHANG IOL CUTTERS OPHTHALMIC SCISSORS HQC MICROSURGICAL TECHNOLOGY, INC. DFH-0012 034683

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention