BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1823634 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01590
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 30, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO INFO" (NO INFO). PRODUCT PROBLEM(S): "IRRIGATION CONTINUED EVEN AFTER TAKING THE FOOT OFF THE FOOTSWITCH" (NO CODE AVAILABLE). THE CUSTOMER REPORTED IRRIGATION CONTINUED EVEN AFTER TAKING THE FOOT OFF THE FOOTSWITCH. NO PT IMPACT WAS REPORTED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI 1020044H

    Patients

    Seq Age Sex Outcome Treatment
    1