BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3102122 · Received April 26, 2013

    Report

    Report Number
    1119279-2013-00138
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS REQUESTED, BUT WAS NOT RETURNED TO BAUSCH+LOMB. 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 INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY FROM THE PT'S EYE DUE TO BENT HAPTIC NOTED UPON INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE PLACED TO CLOSE THE WOUND. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY AND THE PT'S PROGNOSIS WAS REPORTED AS GOOD. PLEASE REF MDR #1119279-2013-00137 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181949 EZ-28 DELIVERY SYSTEM MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other LI61AOR SOFPORT ADVANCED OPTIC LENS (B+L)