BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO ABBOTT MEDICAL

    MDR report key: 2707839 · Received August 13, 2012

    Report

    Report Number
    MW5026525
    Event Type
    Injury
    Date Received
    August 13, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 13, 2012
    Manufacturer
    ABBOT MEDICAL OPTICS
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VERY EARLY IN THE PHACOEMULSIFICATION THE PT HAD A SUDDEN PINCH OF PAIN. PHACOEMULSIFICATION WAS STOPPED AND IT WAS NOTED THAT THE WOUND HAD WIDENED INDICATING A PHACO WOUND BURN. THE WOUND WAS FURTHER WIDENED WITH THE KERATOME AND THE CATARACT WAS REMOVED WITHOUT DIFFICULTY. LENS PLACED. THE EPITHELIUM AND AREA OF THE WOUND BURN WAS BRUSHED OFF WITH THE WECK-CEL AND THE WOUND WAS CLOSED WITH A 10-0 NYLON SUTURE AND OUTER LAYER CLOSED WITH 6-0 CHROMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO ABBOTT MEDICAL AMO SOVREIGN COMPACT PHACO MACHINE HQC ABBOT MEDICAL OPTICS AMO SOVEREIGN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention