BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 2010488 · Received March 1, 2011

    Report

    Report Number
    1119279-2011-00051
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED. IN ADDITION, THE DELIVERY DEVICE WAS NOT RETURNED TO BAUSCH + LOMB FOR EVALUATION, THEREFORE, A ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING A CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE L161SE INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. DURING IMPLANTATION THE SURGEON NOTICED AN UNSPECIFIED DEFECT ON THE LENS. ADDITIONAL INTERVENTION WAS PERFORMED BY ENLARGING THE INCISION TO REMOVE AND REPLACE THE IOL INTRAOPERATIVELY. THE PHYSICIAN IMPLANTED ANOTHER L161SE INTRAOCULAR LENS SUCCESSFULLY WITH NO COMPLICATIONS. REFERENCE MDR #1119279-2011-00050.

    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 60 YR Required Intervention