BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2142157 · Received May 26, 2011

    Report

    Report Number
    2028159-2011-00595
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    April 25, 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
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND HANDPIECE, AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES WERE 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 ONE ADDITIONAL SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING NO ULTRASOUND POWER DURING A CATARACT EXTRACTION PROCEDURE. ADDITIONAL INFORMATION PROVIDED INDICATED THE ISSUE PERSISTED AFTER CHANGING THE HANDPIECE. AN ALTERNATE CONSOLE WAS USED TO COMPLETE THE CASE WITHOUT HARM OR INJURY TO THE PATIENT.

    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 HEALON GV| 0.9MM TAPERED ABS| PROVISC