BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISINO SYSTEM OZIL

    MDR report key: 4152470 · Received October 6, 2014

    Report

    Report Number
    2028159-2014-01837
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    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 NURSE REPORTED THERE WAS NO PHACO POWER DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE CASSETTE AND HANDPIECE WERE EXCHANGED WITH NO RESOLUTION OF THE PROBLEM. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH THE SAME SYSTEM. THERE WAS NO HARM TO THE PT. ALL OTHER CASES FOR THE DAY WERE CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622180 INFINITI VISINO SYSTEM OZIL PHACOFRAGMENTATION SYS HQC ALCON -IRVINE TECH CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1