BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2150678 · Received June 22, 2011

    Report

    Report Number
    2028159-2011-00711
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD DUPLICATE THE REPORTED PROBLEM. THE CPC CONNECTOR WAS BROKEN, BUT IS UNRELATED TO THE REPORTED EVENT. THE CPC CONNECTOR WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED DURING A PROCEDURE, A LOUD POPPING NOISE WAS HEARD COMING FROM THE SYSTEM WHILE THE SURGEON WAS IN THE PHACO MODE. THE SYSTEM WAS EXCHANGED TO COMPLETE THE CASE WITHOUT HARM TO THE PT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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