BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SERVICE

    MDR report key: 4203041 · Received October 23, 2014

    Report

    Report Number
    1119279-2014-00254
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 A BROKEN HAPTIC WAS NOTED INTRAOPERATIVELY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A BACK UP LENS OF THE SAME MODEL WAS IMPLANTED. PLEASE REFERENCE MDR # 1119279-2014-00253 FOR THE LENS USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675995 EZ-28 DELIVERY SERVICE FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB, INC. EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SOFPORT INTRAOCULAR LENS