BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3201704 · Received June 28, 2013

    Report

    Report Number
    1119279-2013-00209
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS REQUESTED, BUT WAS NOT RETURNED TO B+L. 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 INTRAOPERATIVELY REMOVED FROM THE PT'S LEFT EYE DUE TO A TEAR OBSERVED ON THE IOL AFTER IOL INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE USED TO CLOSE THE WOUND. A BACK UP LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY. THE PT'S PROGNOSIS WAS REPORTED AS GOOD. PLEASE REF MDR #1119279-2013-00208 FOR THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295511 VISCOJECT 1.8 DELIVERY SYSTEM MSS/FOLDERS AND INJECTOR IOL MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other AKREOS AO INTRAOCULAR LENS (B+L)