BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTISOL-GS CORNEAL STORAGE MEDIA

    MDR report key: 204177 · Received December 30, 1998

    Report

    Report Number
    2023366-1998-00060
    Event Type
    Other
    Date Received
    December 30, 1998
    Report Date
    November 30, 1998
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    LYX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM ISRAEL STATED THAT PRIMARY GRAFT FAILURE OCCURRED AT ONE DAY POST-OPERATIVELY. THE DONOR CORNEA WAS STORED IN THE CORNEAL STORAGE MEDIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISOL-GS CORNEAL STORAGE MEDIA CORNEAL STORAGE MEDIA LYX BAUSCH & LOMB SURGICAL NA 9816210305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other