BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 1624653 · Received March 5, 2010

    Report

    Report Number
    1610287-2010-00012
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    February 4, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RETURNED FOR EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY INFO TRACEABLE TO THE MFG PROCESS. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED THE PRODUCT DID NOT RETAIN ITS REQUIRED DENSITY. IT "ATTENUATED" ON THE FIRST DAY AFTER SURGERY. THE SURGEON PERFORMED THREE SURGERIES ON THE SAME DAY AND REPORTED THE GAS RETAINED A DENSITY OF 60-70% WHEN IT NORMALLY RETAINS 90% ONE DAY FOLLOWING SURGERY. THE SURGEON DID NOT CHANGE HIS METHOD AND THEREFORE, SUSPECT THE PRODUCT DID NOT MEET ITS SPECIFICATIONS. A LOT NUMBER WAS IDENTIFIED FOR ONE OF THE CASES; THERE WERE NO IDENTIFIERS FOR TWO OF THE CASES. ADD'L INFO HAS BEEN REQUESTED. THIS MEDICAL DEVICE REPORT IS THE TWO CASES WITHOUT IDENTIFIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other