BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDIS CANNULA 27G8MM

    MDR report key: 1222533 · Received November 6, 2008

    Report

    Report Number
    2523835-2008-00007
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V.
    Product Code
    HMX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 11/06/2008

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT AT THE END OF THE SURGERY, WHEN THE SURGEON WENT TO PERFORM A FINAL RINSING OF THE ANTERIOR CHAMBER WITH A SMALL QUANTITY OF IRRIGATING SOLUTION BEFORE CLOSING THE WOUND, THE CANNULA SUDDENLY DISCONNECTED FROM THE SYRINGE AND THE NEEDLE WENT INTO THE EYE. A POSTERIOR CAPSULAR TEAR AND VITREOUS LOSS OCCURRED AS A RESULT OF THE VIOLENT SHOCK WAVE. A VITRECTOMY HAD TO BE PERFORMED. RISK OF COMPLICATIONS WAS REPORTED AS POSSIBLE VISION IMPAIRMENT OF THE AFFECTED EYE. THE SURGICAL STAFF CHECKED THE CANNULA UNDER A MICROSCOPE AFTER THE SURGERY AND THEY SAW IT WAS A LITTLE DAMAGED AT ITS PROXIMAL END. ONE OF THE TWO PLASTIC FLANGES WAS MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDIS CANNULA 27G8MM CANNULA, OPHTHALMIC HMX ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V. 8065441620 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ANTIBIOTICS| VISCOLEASTICS