BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 2113779 · Received June 2, 2011

    Report

    Report Number
    2028159-2011-00614
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    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
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PROBE SPONTANEOUSLY RUPTURED IN THE EYE DURING A VITRECTOMY PROCEDURE. THE PROBE WOULD NOT FIT THROUGH THE TROCAR AND IRIS TRAUMA WAS NOTED UPON REMOVAL. ADDITIONAL INFORMATION PROVIDED INDICATED THE CASE WAS COMPLETED USING A DIFFERENT PROBE WITHOUT FURTHER INCIDENT. THE CURRENT CONDITION OF THE PT IS REPORTED AS STABLE.

    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 Other