BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM TURBOSONIC MICRO TIP

    MDR report key: 5510000 · Received March 18, 2016

    Report

    Report Number
    5510000
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    February 17, 2016
    Report Date
    March 15, 2016
    Manufacturer
    ALCON RESEARCH, LTD
    Product Code
    HQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION SURGERY, THE PHACO TIP BEING USED ON THE PIECE OF EQUIPMENT BROKE OFF IN THE PATIENT'S EYE. THE SURGEON WAS ABLE TO RETRIEVE IT AND IT DID NOT CAUSE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166925 INFINITI VISION SYSTEM TURBOSONIC MICRO TIP APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED HQR ALCON RESEARCH, LTD 8065750159 1429909H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR