BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3255610 · Received July 26, 2013

    Report

    Report Number
    1119279-2013-00238
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 THE PT VISITED THE SURGERY CLINIC COMPLAINING OF DECREASED VISION AND WAS FOUND TO HAVE ENDOPHTHALMITIS THREE DAYS POST IOL IMPLANT. THE PT APPLIED ARTIFICIAL TEARS AND AN ANTI-INFLAMMATORY AGENT AND COMPLETELY RECOVERED BY F/U VISIT ON (B)(6) 2013. ADD'L INFO HAS BEEN REQUESTED. PLEASE REFERENCE MFR# 1119279-2013-00237 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350672 EZ-28 DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other LI61AOR SOFPORT ADVANCED OPTIC LENS (B+L)