BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUJECT 2.2 DELIVERY SYSTEM

    MDR report key: 2963298 · Received February 12, 2013

    Report

    Report Number
    1119279-2013-00042
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WILL NOT BE RETURNED TO B+L FOR EVAL. 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 INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY DUE TO DAMAGE TO THE TRAILING HAPTIC. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE REPLACED. A SECOND LENS WAS IMPLANTED SUCCESSFULLY. ADD'L INFO HAS BEEN REQUESTED. PLEASE REFERENCE MDR#: 1119279-2013-00041 FOR THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61879 ACCUJECT 2.2 DELIVERY SYSTEM HQL/IOL INJECTOR SET HQL MEDICEL AG LP604530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENVISTA ONE PIECE HYDROPHOBIC ACRYLIC IOL