BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPITSOL-GS

    MDR report key: 13011884 · Received December 14, 2021

    Report

    Report Number
    MW5106069
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    December 13, 2021
    Manufacturer
    BAUSCH + LOMB INCORPORATED
    Product Code
    LYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    KPC+ KLEBSIELLA OXYTOCA CULTURED FROM DONOR CORNEA. CANNOT RULE OUT CONTAMINATED OPTISOL-GS TRANSPORT SOLUTION SINCE WE WERE NOT ABLE TO TEST. THE TISSUE WAS RECOVERED INTO OPTISOL-GS, LOT# 2053-025, EXP DATE: 1/8/2023 THE TISSUE WAS THEN TRANSFERRED INTO OPTISOL-GS LOT# 2106-018, EXP 02/17/2023 AFTER ADDITION OF AMPHOTERICIN B (ANTIFUNGAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898154 OPITSOL-GS MEDIA, CORNEAL STORAGE LYX BAUSCH + LOMB INCORPORATED 2053-025
    1898155 OPITSOL-GS MEDIA, CORNEAL STORAGE LYX BAUSCH + LOMB INCORPORATED 2106-018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other