BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3252068 · Received July 24, 2013

    Report

    Report Number
    1119279-2013-00231
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE INTRAOCULAR LENS INTO THE PATIENT'S EYE, THE LENS GOT STUCK IN THE INCISION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS OF THE SAME MODEL WAS IMPLANTED. NO SUTURES WERE REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE REFERENCE MDR # 1119279-2013-00230 FOR THE INTRAOCULAR LENS USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346793 EZ-28 DELIVERY SYSTEM MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other SOFPORT SQUARE EDGE LENS (B+L), LI61SE