BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1472913 · Received July 9, 2009

    Report

    Report Number
    1610287-2009-00021
    Event Type
    Malfunction
    Date Received
    July 9, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 9, 2009
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CYLINDER WAS TESTED BY CHROMATOGRAPH. TEST RESULTS INDICATED THE CYLINDER'S CONTENT WAS CONSISTENT WITH THE CORRECT GAS (SF6). THERE WERE NO ANOMALIES NOTED WITH THE RETURNED CYLINDER. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/09/2009 AND ON 06/24/2009 BY PHONE, FAX AND MAIL. COMPLETED QUESTIONNAIRES HAVE NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A MEDICAL TECHNICIAN REPORTED, THE GAS BUBBLE DID NOT LAST AS LONG AS ANTICIPATED IN THE EYES OF THE FIRST FOUR PATIENTS WHO HAD THIS PRODUCT USED DURING THEIR PROCEDURES. THE SURGEON DID NOT USE THE PRODUCT FOR ANY ADDITIONAL PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON LABORATORIES, INC. NA 905503

    Patients

    Seq Age Sex Outcome Treatment
    1 NI