BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 2994443 · Received March 5, 2013

    Report

    Report Number
    1119279-2013-00060
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WILL NOT BE 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 DURING THE INSERTION OF AN INTRAOCULAR LENS THE HAPTIC RIPPED. THE INCISION WAS ENLARGED, THE LENS WAS REMOVED INTRAOPERATIVELY, AND SUTURES WERE PLACED. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. PLEASE REFERENCE MDR#: 1119279-2013-00059 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94129 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other AKREOS AO INTRAOCULAR LENS (B+L)