BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3949477 · Received July 2, 2014

    Report

    Report Number
    1119279-2014-00158
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DURING DELIVERY THE LENS WAS EJECTED RAPIDLY FROM THE INSERTER CAUSING THE CAPSULE TO BREAK. THE LENS WAS REMOVED INTRAOPERATIVELY FROM THE PT'S EYE, VITRECTOMY WAS PERFORMED, AND THE INCISION WAS ENLARGED TO IMPLANT AN IRIS-FIXATED ANTERIOR CHAMBER IOL. PLEASE REFERENCE MDR#: 1119279-2014-00157 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386057 VISCOJECT 1.8 DELIVERY SYSTEM MSS/FOLDERS AND INJECTOR IOL MSS MEDICEL AG LP604350C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AKREOS MICRO INCISION LENS (B&L)