BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1603701 · Received February 4, 2010

    Report

    Report Number
    1610287-2010-00003
    Event Type
    Injury
    Date Received
    February 4, 2010
    Report Date
    January 5, 2010
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 01/06/2010, 01/07/2010 AND 01/08/2010 BY PHONE. ADDITIONAL INFO WAS RECEIVED 01/06/2010, 01/07/2010, 01/08/2010, 01/12/2010 AND 01/28/2010 BY PHONE AND EMAIL. AN UNCOMPLETED QUESTIONNAIRE WAS RETURNED. (B) (4)

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT IN SEVERAL PTS, THE DURATION OF THE INTRAOCULAR GAS BUBBLE WAS SHORTER THAN EXPECTED. IN A FOLLOW-UP, THE SURGEON REPORTED THAT ONE OR TWO PTS MAY HAVE REQUIRED AN ADDITIONAL PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH/ALCON LABORATORIES, INC. NA 825509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention