BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFLUORON

    MDR report key: 3830559 · Received May 5, 2014

    Report

    Report Number
    1610287-2014-00054
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LWL
    PMA / PMN Number
    P950018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT LOT CODE OR SAMPLE IS AVAILABLE IN CONJUNCTION WITH THIS LITERATURE REPORT. WITH NO LOT CODE INFORMATION OR COMPLAINT SAMPLE, NO FURTHER EVALUATION CAN BE PERFORMED. PER THE PRODUCT LABELING, PERFLUORO-N-OCTANE MUST BE COMPLETELY REMOVED AT THE END OF THE SURGICAL PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE DESCRIBING A STUDY OF 181 PATIENTS WITH INFERIOR RETINAL DETACHMENT TREATED WITH INTERMEDIATE DURATION POSTOPERATIVE VITREOUS CAVITY PER FLUORO-N-OCTANE IN APPROXIMATELY 30 PERCENT OF THE PATIENTS WHICH WAS APPARENT AT SEVEN TO TEN DAYS AFTER THE INITIAL PRODUCT INSTILLATION FOR RHEGMATOGENOUS RETINAL DETACHMENT REPAIR WAS PERFORMED. NO FURTHER INFORMATION IS EXPECTED FOR THIS LITERATURE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267380 PERFLUORON FLUID, INTRAOCULAR LWL ALCON - FORT WORTH/ALCON LABORATORIES, INC. 8065900112 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK.