BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFLUORON

    MDR report key: 2954035 · Received November 28, 2007

    Report

    Report Number
    1610287-2007-00067
    Event Type
    Injury
    Date Received
    November 28, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ALCON - FORT WORTH, ALCON LABORATORIES, INC.
    Product Code
    LWL
    PMA / PMN Number
    P950018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT BEING RETURNED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING RECORDS. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. LABELING STATES PRODUCT MUST BE COMPLETELY REMOVED FROM THE EYE, AND REPLACED WITH AN APPROPRIATE VITREOUS SUBSTITUTE. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTS PRODUCT REMAINED IN THE EYE FOLLOWING SURGERY. THE RESIDUAL PRODUCT WAS SUBSEQUENTLY REMOVED. ADDITIONAL INFORMATION INCLUDING THE PATIENT'S CURRENT STATUS HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFLUORON RETINAL STABILIZING ADJUNCT LWL ALCON - FORT WORTH, ALCON LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention