BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 1983861 · Received February 4, 2011

    Report

    Report Number
    1119279-2011-00031
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DELIVERY DEVICE REVEALED A BENT TIP. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE DELIVERY DEVICE. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF AN LI61AOR INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. INTRAOPERATIVELY, THE SURGEON NOTED THAT A HAPTIC WAS PROTRUDING AND SUBSEQUENTLY REMOVED THE IOL AND IMPLANTED ANOTHER INTRAOCULAR LENS. THE INCISION WOULD WAS SUTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR #1119279-2011-00030.

    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 LI61AOR INTRAOCULAR LENS (B&L)