BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 4152510 · Received October 6, 2014

    Report

    Report Number
    2028159-2014-01828
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 12, 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
    LO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS PERFORMED. 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 INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE CABLE OF THE FOOTSWITCH WAS LOOSENING DURING CALIBRATION OF THE SYSTEM. THERE WAS NO PT INVOLVEMENT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622278 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1