BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1940109 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02417
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 29, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM. THE KEYBOARD AND TOUCH SCREEN WERE REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE OIL EXTRACTION FUNCTION WAS NOT WORKING PROPERLY. THIS EVENT WAS REPORTED TO HAVE OCCURRED DURING A PROCEDURE. THE SURGERY WAS DELAYED BUT THE LENGTH OF THE DELAY IS UNK. THERE WAS NO PT IMPACT REPORTED. ADD'L INFO HAS BEEN REQUESTED.

    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