BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 1894957 · Received November 5, 2010

    Report

    Report Number
    2028159-2010-02148
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE TROCAR FROM A 25 GAUGE HAD BROKEN OFF IN A PT'S EYE AND WAS NOT RETRIEVABLE. ADDITIONAL INFO, RECEIVED BY THE OPERATING ROOM SUPERVISOR, INDICATED AT THE END OF A TOTAL PENETRATING KERATOPLASTY (TPK) AND VITRECTOMY, WHEN THE SURGEON TRIED TO REMOVE THE TROCAR, IT BROKE OFF AND FELL BACK INTO THE PT'S EYE. BECAUSE THE CORNEA WAS CLOUDY FROM THE TPK, THE SURGEON WAS UNABLE TO SEE IT SO DID NOT RETRIEVE IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention