BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 2010871 · Received March 3, 2011

    Report

    Report Number
    1119279-2011-00055
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    January 7, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON DID NOT CONCLUSIVELY IDENTIFY THE CAUSE OF THE EVENT, BUT INDICATED THAT IT MIGHT BE DUE TO A POSSIBLE LOADING ERROR.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH AN ATTEMPTED IMPLANTATION OF A (B)(4) INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. INTRAOPERATIVELY, THE SURGEON NOTICED THE HAPTIC WAS BENT AND SUBSEQUENTLY ENLARGED THE INCISION TO REMOVE THE LENS. THE IOL WAS REPLACED WITH ANOTHER INTRAOCULAR LENS OF UNSPECIFIED MODEL. REFERENCE MDR #1119279-2011-00054.

    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