BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFPORT DELIVERY SYSTEM

    MDR report key: 4638420 · Received March 20, 2015

    Report

    Report Number
    1313525-2015-00434
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 WHILE INSERTING THE LENS IN THE PATIENT'S EYE, THE LENS INJECTOR CRACKED AND SPLIT, MAKING THE LENS COME OUT THE SIDE OF THE INJECTOR. LENS WAS NOT IMPLANTED AND THE BACK UP LENS WAS IMPLANTED WITH NO ISSUES. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192026 SOFPORT DELIVERY SYSTEM FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28V H466501

    Patients

    Seq Age Sex Outcome Treatment
    1