BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2030986 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00222
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE SYSTEM "SPARKED" DURING A PROCEDURE. THE PT WAS RELEASED. AT LEAST 12 PROCEDURES WERE CANCELED. ADDITIONAL INFO WAS REQUESTED. SEVERAL ATTEMPTS HAVE BEEN MADE TO ACQUIRE ADDITIONAL INFO, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1