BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 1910816 · Received November 23, 2010

    Report

    Report Number
    1119279-2010-00099
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDERGOING EVAL.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE LI61AOR INTRAOCULAR LENS USING THE EZ-28 INSERTER. DURING INSERTION, THE SURGEON OBSERVED THAT THE HAPTIC WAS TWISTED PREVENTING IT FROM BEING DELIVERED INTO THE CAPSULAR BAG. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION, REMOVE AND REPLACE THE LENS, AND SUTURE THE WOUND. ADDITIONAL INFO HAS BEEN REQUESTED. REFERENCE MDR 119279-2010-00098.

    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)