BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8

    MDR report key: 3059649 · Received April 5, 2013

    Report

    Report Number
    1119279-2013-00099
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ADVANCING THE PLUNGER THE LOADING WINGS ON THE INJECTOR DETACHED COMPLETELY FROM THE INJECTOR BARREL. THE BLUE SILICONE TIP ADVANCED THROUGH THE TIP OF THE INJECTOR AND GOT STUCK IN THE WOUND. THE LENS WAS DELIVERED SUCCESSFULLY. A STITCH WAS REQUIRED TO SEAL THE WOUND. NO INFO WAS RECEIVED REGARDING THE IMPLANTED LENS. ADDITIONAL INFO HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140077 VISCOJECT 1.8 MSS; INJECTORS, INTRAOCULAR LENS (IOL) MSS MEDICEL AG LP604350 1243A03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other