BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 1221257 · Received November 5, 2008

    Report

    Report Number
    2028159-2008-00402
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TROCAR WAS REC'D FOR EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE TROCAR CANNULA BROKE WHILE IN THE EYE. THE SURGEON ENLARGED THE SCLEROTOMY TO RETRIEVE THE EMBEDDED BROKEN TROCAR. THE SURGEON SUTURED THE WOUND. THE PT OUTCOME IS EXCELLENT.

    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