BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1747639 · Received July 2, 2010

    Report

    Report Number
    1610287-2010-00073
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. ELEVATED IOP IS NOTED AS AN OPERATIVE AND POSTOPERATIVE COMPLICATION IN THE LABELING/DIRECTIONS FOR USE (DFU) FOR THIS PRODUCT. ADDITIONAL INFO WAS REQUESTED ON 06/04/2010, 06/07/2010, 06/08/2010, 06/10/2010 AND 06/22/2010 BY PHONE, FAX AND MAIL. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "ELEVATED IOP" (INTRAOCULAR PRESSURE RISE). PRODUCT PROBLEM(S): "NO INFORMATION" (NO INFORMATION). A SURGEON REPORTED THREE PTS EXPERIENCED ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING RETINOPEXY PROCEDURES WHERE THIS PRODUCT WAS USED AT 20% DILUTION WITH FILTERED ROOM AIR. THERE ARE NO PT IDENTIFIERS AVAILABLE AT THIS TIME. 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 010308

    Patients

    Seq Age Sex Outcome Treatment
    1 NI