BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFLUORON

    MDR report key: 1993692 · Received February 11, 2011

    Report

    Report Number
    1610287-2011-00012
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 25, 2008
    Report Date
    January 12, 2011
    Manufacturer
    ALCON - FORTH WORTH / ALCON LABORATORIES, INC.
    Product Code
    LWL
    PMA / PMN Number
    P950018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INSERT / DIRECTIONS FOR USE (DFU) STATES PERFLUORON MUST BE COMPLETELY REMOVED FROM THE EYE AND REPLACED WITH AN APPROPRIATE VITREOUS SUBSTITUTE. ALSO THE LITERATURE PROVIDES PRECAUTIONS TO AVOID INADVERTENT PLACEMENT OF PERFLUORON BEHIND THE RETINA DURING INJECTION, THE FINAL FILL LEVEL IN THE EYE SHOULD ALWAYS REMAIN POSTERIOR TO ANY LARGE RETINAL BREAKS. ADDITIONALLY, THE LITERATURE STATES IF PERFLUORON IS INTRODUCED INTO A LARGE RETINAL BREAK, IT MAY SLIP INTO THE SUBRETINAL SPACE. SPECIAL CARE SHOULD BE TAKEN TO EXAMINE FOR AND REMOVE ANY SUBRETINAL PERFLUORON THROUGH AN EXISTING POSTERIOR TEAR OR THROUGH A POSTERIOR RETINOTOMY PRIOR TO COMPLETION OF SURGERY. NO LOT CODE WAS PROVIDED AND NO SAMPLE WAS RETURNED SO NO FURTHER INVESTIGATION COULD BE PERFORMED AT THIS TIME. LITERATURE CITATION: HAJIME BANDO, TOSHIHIDE IKEDA, KOJI NAKAJIMA, TAKAMASA MINAMI, ERIKO NAKATANI, RYO LISHI, TOMOHITO TANAKA, KOSAKU SAWADA, YOSHIHITO OURA, TATSUHIKO SATO AND KAZUYUKI EMI: ANALYSIS OF CASES WITH PERFLUOROCARBON LIQUID REMAINING IN EYES. ABSTRACTS OF THE 34TH ANNUAL MEETING OF THE (B)(4) SOCIETY OF OPHTHALMOLOGY. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 02/11/2011. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE REPORTS: A (B)(6) YEAR-OLD, MALE, UNDERWENT SURGERY FOR RETINAL DETACHMENT REPAIR. A VITRECTOMY AND SILICONE OIL TAMPONADE WAS PERFORMED AND PERFLUORO-N-OCTANE (PFO) WAS USED. DURING THE TWO-WEEK POSTOPERATIVE EXAM THE SURGEON NOTED PFO RESIDUES UNDER THE RETINA, IN TWO SPOTS. THE SURGEON COULD NOT JUDGE IF THERE WAS PATIENT HARM DUE TO THE EYE WAS FILLED WITH THE SILICONE OIL. TWO MONTHS FOLLOWING THE INITIAL PROCEDURE THE RESIDUAL PFO WAS REMOVED ALONG WITH THE SILICONE OIL. THIS IS THE FIRST OF FOUR MEDICAL DEVICE REPORTS BEING FILED FOR THIS LITERATURE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SILICONE OIL