BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3074202 · Received April 12, 2013

    Report

    Report Number
    1119279-2013-00123
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE HAS BEEN RETURNED TO B+L FOR EVALUATION. 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 INJECTOR TIP SPLIT DURING IOL INSERTION. INCISION WAS NOT ENLARGED FOR DEVICE REMOVAL. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY AND SUTURES WERE PLACED. DURING A FOLLOW UP VISIT THE SUTURES WERE PLACED. DURING A FOLLOW UP VISIT THE SUTURES WERE REMOVED AND THE PATIENT IS DOING FINE. PLEASE REFERENCE MDR#: 1119279-2013-00122 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158866 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LP604350 123403

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AKREOS AO INTRAOCULAR LENS (B+L)