BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUJECT 2.2 DELIVERY SYSTEM

    MDR report key: 2890562 · Received December 20, 2012

    Report

    Report Number
    1119279-2012-00333
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDICEL AG
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 MX60 INTRAOCULAR LENS WAS INSERTED INTO THE PT'S EYE AND REMOVED INTRAOPERATIVELY DUE TO DAMAGED HAPTIC THAT WAS NOTED DURING INSERTION. AN ACCUJECT 2.2 INSERTER WAS USED. THE INCISION WAS SLIGHTLY ENLARGED TO EXCHANGE THE LENS, BUT SUTURES WERE NOT NEEDED TO CLOSE THE WOUND. NO FURTHER COMPLICATIONS POST OPERATION REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. PLEASE REF MDR#: 1119279-2012-00332 FOR THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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