BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 4122553 · Received September 22, 2014

    Report

    Report Number
    2028159-2014-01749
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON NOTED SMALL PIECES OF METAL ON A FEMALE PATIENT'S IRIS POST OPERATIVELY. THE PATIENT'S EYE AT THIS TIME IS QUIET. THERE WAS NO ADDITIONAL MEDICATION THERAPY USED POST-OPERATIVELY. THE SURGEON SUSPECTS THIS MAY BE CAUSED BY NOT FOLLOWING THE RECOMMENDED CLEANING INSTRUCTIONS FOR THE HANDPIECE. THIS REPORT IS THE SECOND OF TWO PATIENTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587800 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR I/A HANDPIECE THREADED STTL