BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1791887 · Received August 4, 2010

    Report

    Report Number
    2028159-2010-01381
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    June 26, 2010
    Report Date
    July 5, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT IMPACT" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "BROKEN OPTICAL FIBER" (BREAK). A CUSTOMER REPORTED A BROKEN OPTICAL FIBER. ADDITIONAL INFORMATION WAS REQUESTED. NO PATIENT IMPACT WAS REPORTED. MULTIPLE ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFORMATION, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 10010691X

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR