BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 3901673 · Received May 7, 2014

    Report

    Report Number
    2028159-2014-00841
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 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). THIS REPORT WAS MAILED TO FDA ON 05/08/2014. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED POOR ASPIRATION DURING A VITRECTOMY PROCEDURE. THE CASE WAS COMPLETED WITH NO HARM TO THE PT. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275543 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON-IRVINE TECH CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK