BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFLUORON

    MDR report key: 1133094 · Received August 22, 2008

    Report

    Report Number
    1610287-2008-00031
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ALCON - FORT WORTH/ ALCON LABORATORIES, INC.
    Product Code
    LWL
    PMA / PMN Number
    P950018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND THREE UNOPENED SAMPLES WERE RETURNED FOR EVALUATION. 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 INFORMATION BECOMES AVAILABLE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER.

    Description of Event or Problem · 1

    A SURGEON REPORTED PRODUCT APPEARED LIKE FISH EGGS IN THE PATIENT'S EYE DURING SURGERY. THE SURGEON REMOVED THE PRODUCT AT THAT TIME, AND THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFLUORON FLUID, INTRAOCULAR LWL ALCON - FORT WORTH/ ALCON LABORATORIES, INC. 8065900113 148765F

    Patients

    Seq Age Sex Outcome Treatment
    1