BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 2003629 · Received February 23, 2011

    Report

    Report Number
    1119279-2011-00046
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED BY THE CUSTOMER. THE DELIVERY DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    THE SURGEON REPORTS ATTEMPTING TO IMPLANT THE LI61AO LENS BUT THE HAPTICS COULD NOT BE POSITIONED PROPERLY. THE SURGEON ENLARGED THE INCISION, REMOVED THE LENS, AND IMPLANTED AN ANTERIOR CHAMBER LENS. IN ADDITION, A VITRECTOMY WAS PERFORMED. REFERENCE MDR #1119279-2011-00045.

    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 Required Intervention L161AO INTRAOCULAR LENS (B&L)