BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2161014 · Received June 17, 2011

    Report

    Report Number
    2028159-2011-00709
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. THE COMPANY REPRESENTATIVE TESTED THE CUSTOMERS HANDPIECE AND TIP AND FOUND NO PROBLEM. 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 NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING PHACOEMULSIFICATION, THE SYSTEM STOPPED WORKING. IT TOOK APPROXIMATELY ONE HOUR TO TROUBLESHOOT AND GET THE SYSTEM TO WORK AGAIN. THE SURGERY WAS COMPLETED AND THE NURSE REPORTED THAT THERE WAS NO HARM OR INJURY DUE TO THE DELAY.

    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 UNK