BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORNEAL IMPLANT

    MDR report key: 555666 · Received February 25, 2004

    Report

    Report Number
    555666
    Event Type
    Other
    Date Received
    February 25, 2004
    Date of Event
    December 31, 2003
    Report Date
    January 14, 2004
    Manufacturer
    THE EYE BANK FOR SIGHT RESTORATION
    Product Code
    LMO
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT CORNEAL TRANSPLANT OF THE RIGHT EYE. THE PATIENT WAS DISCHARGED ON THE SAME DAY. THE EYE SURGEON REPORTED THAT THE PATIENT DEVELOPED POST-OP EYE INFECTION AND SOUGHT TREATMENT AT OTHER HOSPITAL. IN 2004, THE PATIENT UNDERWENT SURGERY TO THE RIGHT EYE FOR LOOSE CORNEAL GRAFT SUTURES. ADDITIONAL SUTURES WERE ADDED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. AS PER PROTOCOL, THE CORNEOSCLERAL RIM MEDIA WAS CULTURED FOR AEROBIC, ANAEROBIC AND FUNGAL CULTURES AT TIME OF SURGERY. THE RESULTS RETURNED POSITIVE FINDINGS. THE TISSUE BANK (THE EYE BANK FOR SIGHT RESTORATION, INC.) WHICH SUPPLIED THE CORNEAL IMPLANT WAS NOTIFIED ON JANUARY 7, 2004 AND THEY HAVE INITIATED THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORNEAL IMPLANT CORNEAL IMPLANT LMO THE EYE BANK FOR SIGHT RESTORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR