BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1992859 · Received February 4, 2011

    Report

    Report Number
    2028159-2011-00091
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 5, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST FIELD SERVICE. THE CUSTOMER INDICATED THAT THE BIOMED HAD TURNED THE UNIT ON AND OFF MULTIPLE TIMES WITH NO SYSTEM MESSAGES. THE BIOMED INDICATED THAT THE UNIT WOULD BE PLACED BACK IN SERVICE. NO SAMPLES ARE EXPECTED TO BE RETURNED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SYSTEM DISPLAYED MULTIPLE SYSTEM MESSAGES. THE FACILITY'S BACK UP UNIT WAS USED TO COMPLETE THE CASES. PT IMPACT IS UNK. ADDITIONAL INFO WAS 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