BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 3901688 · Received May 7, 2014

    Report

    Report Number
    2028159-2014-00843
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED POOR ASPIRATION AND SUSPECTED FLUID LEAKING DURING A PROCEDURE. HOWEVER, THE ASPIRATION WAS CONFIRMED AT 550MMHG, AND NO LEAKING IN THE SYSTEM WAS OBSERVED. THE CASE WAS COMPLETED WITH NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275546 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECH CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK