BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 600DS

    MDR report key: 3853313 · Received April 4, 2014

    Report

    Report Number
    2028159-2014-00603
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    March 5, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY VENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT HAS BEEN DONE AND THE INVESTIGATION IS STILL 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE DURING AN OPHTHALMIC PROCEDURE. AN ALTERNATE SYSTEM WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204833 ACCURUS 600DS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY VENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1