BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 996780 · Received February 7, 2008

    Report

    Report Number
    2028159-2008-00059
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Report Date
    January 11, 2008
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K951627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO BECOMES AVAILABLE. THIS REPORT MAILED IN TO FDA ON: 02/07/2008.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS INITIATED FROM LITERATURE IN THE OPHTHALMIC COMMUNICATIONS SOCIETY, INC. VOLUME 25 (7). OCTOBER/NOVEMBER 2005. PP 942-943. THE ARTICLE STATES A FEW SECONDS AFTER STARTING THE SILICONE OIL INJECTION INTO THE POSTERIOR CHAMBER AT 50 MMHG, THE GLASS SYRINGE CONTAINING THE SILICONE OIL EXPLODED. THE CUSTOMER WAS USING CENTISTOKE SILICONE OIL (ADATO SIL-OL-5000) 10 ML GLASS SYRINGE MANUFACTURED BY BAUSCH & LOMB INC, ROCHESTER NY WITH THE VISCOUS FLUID INJECTION PAK (ALCON MANUFACTURED) AND THE ALCON OPTHALMIC SURGICAL SYSTEM. NO INJURIES TO THE PT OR PERSONNEL IN THE OPERATING ROOM OCCURRED. MULTIPLE ATTEMPTS MADE TO CONTACT THE SURGEON/AUTHOR OF THE ARTICLE WITH NO RESPONSE. BAUSCH AND LOMB WAS CONTACTED AND ADVISED OF THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS OPHTHALMIC SURGERY SYSTEM HQC ALCON-IRVINE TECHNOLOGY CENTER ACCURUS 800CS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CENTISTOKE SILICONE OIL (ADATO -SIL-OL-5000)| 10 ML GLASS SYRINGE.