BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 1935809 · Received December 3, 2010

    Report

    Report Number
    2028159-2010-02292
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE DURING A CASE. THE SURGEON COMPLETED THE PROCEDURE USING A MANUAL TECHNIQUE FOR THE SILICONE OIL INJECTION. THE PT WAS UNDER ANESTHESIA AT THE TIME OF THE EVENT. THERE WAS NO PT HARM REPORTED. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFO, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1