BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3123614 · Received May 17, 2013

    Report

    Report Number
    1119279-2013-00156
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS REQUESTED, BUT WAS NOT 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 LENS WAS INTRAOPERATIVELY REMOVED FROM THE PATIENT'S LEFT EYE AS ONE HAPTIC APPEARED UNUSUAL TO THE SURGEON. THE INCISION WAS ENLARGED TO REMOVE THE LENS AN SUTURES WERE USED TO CLOSE THE WOUND. A BACK UP LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY. THE PATIENT'S PROGNOSIS WAS REPORTED AS NORMAL. PLEASE REFERENCE MDR#: 1119279-2013-00155 FOR THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219317 VISCOJECT 1.8 DELIVERY SYSTEM MSS / IOL INJECTOR SET MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other AKREOS AO INTRAOCULAR LENS (B+L)