BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3213567 · Received July 3, 2013

    Report

    Report Number
    1119279-2013-00213
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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 THE SUPERIOR ZONULES BROKE UPON LENS INSERTION, AND THE LENS VAULTED. LENS WAS REMOVED INTRAOPERATIVELY AND A VITRECTOMY WAS PERFORMED. ANOTHER LENS OF DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. THE SURGEON INDICATED THAT IN HIS OPINION THE EVENT WAS LIKELY DUE TO PT CONDITION OF ZONULAR WEAKNESS. THE PT'S CURRENT PROGNOSIS WAS DESCRIBED AS "PT HAS DONE VERY WELL". THIS REPORT PERTAINS TO THE PT'S RIGHT EYE. PLEASE REFERENCE MDR #:1119279-2013-00212 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304447 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other AKREOS AO INTRAOCULAR LENS (B+L)