BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON EYE SPEARS-CELLULOSE SPONGES- 10/PK

    MDR report key: 1477355 · Received September 15, 2009

    Report

    Report Number
    MW5012753
    Event Type
    Malfunction
    Date Received
    September 15, 2009
    Report Date
    September 15, 2009
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT PROBLEM WITH CELLULOSE EYE SPEARS. SPEARS ARE CONTAINED IN CUSTOM CATARACT TRAY MFG BY ALCON LABORATORIES, INC. CATALOG NUMBER 11036-11. SPEARS CATALOG NUMBER IS 100010001. PHYSICIAN HAS NOTICED THAT EYE SPEARS-CELLULOSE SPONGES-APPEAR TO SHED STRANDS OF FIBER. THESE ARE NOTICED PRIOR TO USING IN EYE SURGERY CASES AND CAN POTENTIALLY CAUSE PROBLEMS IF FIBERS WERE TO GET INTO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON EYE SPEARS-CELLULOSE SPONGES- 10/PK EYE SPEARS HOZ ALCON LABORATORIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1