BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2152252 · Received June 23, 2011

    Report

    Report Number
    2028159-2011-00698
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 24, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. THE SYSTEM EVENT LOG WAS REVIEWED AND NO SYSTEM MESSAGES WERE FOUND ASSOCIATED WITH THE CUSTOMER REPORTED EVENT. THE COMPANY REPRESENTATIVE TESTED THE CUSTOMER'S HANDPIECES AND ALL PERFORMED TO SPECIFICATIONS. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED 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 INDICATE TWO ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED LOW PHACO POWER WAS EXPERIENCED DURING A CATARACT EXTRACTION PROCEDURE. THE CASE TOOK LONGER TO PERFORM, HOWEVER, THERE WAS NO DELAY OR HARM TO THE PATIENT. THIS IS THE SECOND OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    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 58 YR