BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 2167101 · Received July 14, 2011

    Report

    Report Number
    3002037047-2011-00041
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A CHECK OF THE COMPLAINT RECORDS SHOWED NO SIMILAR COMPLAINTS AGAINST LOT # 017511. A CHECK OF THE BATCH PRODUCTION RECORD SHOWED NO UNUSUAL MANUFACTURING ISSUES. CYLINDER 23 OF LOT # 017511, EXPIRATION DATE 06/2112, WAS RETURNED. THE RETURNED PRODUCT WAS ANALYZED AND FOUND TO MEET RELEASE CRITERIA. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE CUSTOMER COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED BY MAIL ON 04/14/2011 AND BY PHONE ON 04/18/2011, 05/05/2011 AND 05/26/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 06/14/2011. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN INDUSTRIAL HYGIENIST REPORTED THE CANISTER FORMULA WAS SUSPECTED TO BE DEFECTIVE. ON (B)(6) 2011, THE OPHTHALMIC SURGEON DESCRIBED THE EVENT AS A PARS PLANA VITRECTOMY WITH ENDO LASER AND GAS: CF8 AT 14% TREATMENT FOR MACULAR DEGENERATION ON A RETINAL DETACHMENT. THE SURGEON REPORTED THAT APPROXIMATELY 24 HOURS FOLLOWING SURGERY, THE GAS INJECTION IN THE EYE WAS ALMOST HALF GONE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR AN ADDITIONAL GAS INJECTION. THE SURGEON REPORTED THE EVENT RESOLVED WITH TREATMENT.

    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 017511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other