BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUOVISC

    MDR report key: 7104559 · Received December 8, 2017

    Report

    Report Number
    MW5073882
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    December 6, 2017
    Report Date
    December 6, 2017
    Manufacturer
    ALCON LABORATORIES INC.
    Product Code
    LZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ORDERED DUOVISC AND VISCOAT FROM ALCON LABORATORIES, INC. AND PRODUCT ARRIVED AT 58.8 DEGREES F. THIS IS THE THIRD TIME WE HAVE ORDERED PRODUCT FROM ALCON WHICH HAS ARRIVED OVER LABELED TEMPERATURE RANGE OF 36 TO 46 DEGREE F. WE NOTIFIED ALCON LABORATORIES, INC. OF THE ISSUE. IN RESPONSE THEY STATED AS LONG AS THE PRODUCT DOES NOT EXCEED 80 DEGREES F IT WAS OK TO USE. HOWEVER THEIR WRITTEN DOCUMENTATION PROVIDED SAYS "ALCON LABORATORIES INC. CANNOT ASSURE THE EFFECTIVENESS OF THESE PRODUCTS NOR RECOMMEND THEIR USE ONCE THEY ARE STORED OUTSIDE OF THE LABELED GUIDELINES." UPON REVIEW OF THE PACKAGE INSERT IT CLEARLY STATES TEMPERATURE RANGE OF 36 TO 46 DEGREES F. THE COLD CHAIN MANAGEMENT OF THE PRODUCT IS NOT KEEPING WITH LABELED GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881526 DUOVISC DUOVISC LZP ALCON LABORATORIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1