BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 2181189 · Received July 21, 2011

    Report

    Report Number
    1119279-2011-00134
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS NOT RETURNED TO BAUSCH AND LOMB FOR EVALUATION. THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. BASED ON THE CURRENT INFORMATION, WE ARE UNABLE TO DETERMINE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LI61SE LENS WAS INSERTED INTO THE PATIENT'S RIGHT EYE AND IMMEDIATELY REMOVED AS THE HAPTIC KINKED INTRAOPERATIVELY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER IOL OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. SUTURES WERE NECESSARY TO CLOSE THE WOUND. REFERENCE MDR# 1119279-2011-00133.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-28 DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other SILICONE SQUARE EDGE INTRAOCULAR LENS (B+L)