BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3060363 · Received April 11, 2013

    Report

    Report Number
    1119279-2013-00107
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERTER HAS BEEN RETURNED TO B&L AND IS CURRENTLY UNDER EVAL. 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 THE LENS WAS REMOVED INTRAOPERATIVELY DUE TO BENT HAPTIC. INCISION WAS ENLARGED TO REMOVE LENS AND ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. NO SUTURES WERE NEEDED. THIS REPORT PERTAINS TO THE PT'S LEFT EYE. THE PT'S MOST CURRENT STATUS UCVA IS 20/25. PLEASE REFERENCE MDR# 1119279-2013-00106 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155503 EZ-28 DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28 H233501

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other LI61AOR SOFPORT ADVANCED OPTIC LENS (B&L)