BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2501088 · Received March 19, 2012

    Report

    Report Number
    MW5024730
    Event Type
    Injury
    Date Received
    March 19, 2012
    Date of Event
    January 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    ALCON
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS IN PROCESS OF PEELING INNER LIMITING MEMBRANE WITH DISPOSABLE PNEUMATIC FORCEPS OF THE ALCON CONSTELLATION SURGICAL DEVICE. HE HAD SUCCESSFULLY PEELED SOME OF THE MEMBRANE WHEN THE TIP SHOT OFF HANDPIECE AND "SARTED" THE RETINA. SUBSTANTIAL DAMAGE TO THE EYE RESULTED. UNKNOWN AMOUNT OF DISABILITY OR PERMANENT DAMAGE AT THIS TIME. THE SURGICAL CASE COULD NOT BE COMPLETED DUE TO SUBSTANTIAL HEMORRHAGE AND NEW RETINAL TEARS. REASON FOR USE: MACULAR HOLE IN RIGHT EYE, BLURRED VISION - HISTORY OF VITRECTOMY / MEMBRANECTOMY; FLUID/GAS EXCHANGE - SGY PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VISION SYSTEM CONSTELLATION HQC ALCON 1001748001X 1001748001X

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other DISPOSABLE FORCEPS| DISPOSABLE HANDPIECE