BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUJECT 2.2 DELIVERY DEVICE

    MDR report key: 2855680 · Received November 30, 2012

    Report

    Report Number
    1119279-2012-00301
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDICEL AG
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC GOT CAUGHT IN THE INSERTER AND BECAME BENT DURING INSERTION OF THE ENVISTA ((B)(4)) INTRAOCULAR LENS. THE INCISION WAS ENLARGED, ANOTHER LENS WAS SUCCESSFULLY IMPLANTED, AND SUTURES WERE PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE REFERENCE MDR#: 1119279-2012-00300 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUJECT 2.2 DELIVERY DEVICE HQL/IOL INJECTOR SET HQL MEDICEL AG LP604530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other