BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2960336 · Received February 8, 2013

    Report

    Report Number
    2028159-2013-00091
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY THE TIME A COMPANY REPRESENTATIVE CONTACTED THE CUSTOMER, THE CUSTOMER INDICATED THAT THE SYSTEM WAS FUNCTIONING NORMALLY. THEREFORE, NO FURTHER SERVICE WAS REQUESTED. NO SAMPLES WERE RETURNED FOR FURTHER EVALUATION. ADDITIONALLY, A REVIEW OF THE SYSTEM'S EVENT LOG DID NOT INDICATE ANY RELATED SYSTEM MESSAGES. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SYSTEM TURNED OFF DURING A PROCEDURE. THE PROCEDURE WAS CONVERTED TO A MANUAL TECHNIQUE AND THE SURGERY WAS COMPLETED WITH NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54101 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other