BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY DEVICE

    MDR report key: 1936255 · Received December 14, 2010

    Report

    Report Number
    1119279-2010-00129
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO THE INJECTOR.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE LI61AOR INTRAOCULAR LENS IN THE RIGHT EYE USING THE EZ-28 DELIVERY DEVICE. DURING INSERTION, THE LEADING HAPTIC BECAME BENT AND THE TRAILING HAPTIC CAUGHT IN THE INJECTOR AND WAS BENT. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. A SECOND LI61AOR INTRAOCULAR LENS WAS IMPLANTED SUCCESSFULLY AND THE WOUND WAS SUTURED. REFERENCE MDR #1119279-2010-000128.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LI61AOR INTRAOCULAR LENS (B+L)