BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3005960 · Received March 12, 2013

    Report

    Report Number
    1119279-2013-00068
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    November 12, 2012
    Report Date
    February 11, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE HAS NOT BEEN RETURNED TO BAUSCH AND LOMB 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 LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE INTRAOPERATIVELY DUE TO A HOLE IN THE CAPSULAR BAG THAT WAS NOTED UPON LENS INSERTION. VITRECTOMY WAS PERFORMED AND ANOTHER LENS OF DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY. THE PATIENT'S PROGNOSIS WAS REPORTED AS "FINE." PLEASE REFERENCE MDR# : 1119279-2013-00067 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103532 VISCOJECT 1.8 DELIVERY SYSTEM MSS/FOLERS AND INJECTOR IOL MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other AKREOS MICRO INCISION LENS