BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3880986 · Received April 7, 2014

    Report

    Report Number
    2028159-2014-00427
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 11, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. THE COMPANY REPRESENTATIVE STATED THAT THE USER SELECTED THE INCORRECT SETTING ON THEIR SYSTEM. THE COMPANY REPRESENTATIVE INSTRUCTED THE CUSTOMER HOW TO SELECT THE CORRECT SETTINGS. THE COMPANY REPRESENTATIVE THEN, TESTED THE SYSTEM AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SYSTEM MADE A "STRANGE" NOISE AND THERE WAS NO ULTRASOUND DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207715 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK