BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISOL-GS CORNEAL STORAGE MEDIA

    MDR report key: 1375262 · Received February 20, 2009

    Report

    Report Number
    1920664-2009-00044
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYX
    PMA / PMN Number
    K894162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING THE VIAL CONTAINING THE DONOR CORNEA THE USER DETECTED A STRONG ODOR. THE DONOR CORNEA WAS NOT USED. THE PATIENT HAD BEEN PREPARED FOR SURGERY INCLUDING THE USE OF ANESTHESIA. THE PT WAS RESCHEDULED AND THE TRANSPLANT WAS SUCCESSFULLY PERFORMED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISOL-GS CORNEAL STORAGE MEDIA LYX BAUSCH & LOMB NA W0004779

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK