BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2172623 · Received June 24, 2011

    Report

    Report Number
    2028159-2011-00728
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 26, 2011
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT THE EVAL HAS NOT BEEN COMPLETED. 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

    A CUSTOMER REPORTED THAT DURING SURGERY, THE BALANCED SALT SOLUTION RATE WAS SLOWER THAN USUAL. ON EXAMINATION, A SMALL HOLE IN THE INFUSION CANNULA WAS FOUND. A NEW VITRECTOMY PAK WAS OBTAINED AND THE CASE WAS COMPLETED. THERE WAS NO HARM TO THE PT REPORTED.

    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 UNK TOTAL PLUS PAK| BALANCED SALT SOLUTION