BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3851891 · Received April 17, 2014

    Report

    Report Number
    2028159-2014-00692
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED FOR THE CUSTOMER HAVING A VACUUM PROBLEM. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, THE MANUFACTURING DEVICE HISTORY RECORD FOR THIS COMPLAINT COULD NOT BE REVIEWED. THE ROOT CAUSE FOR THE POOR VACUUM APPEARS TO BE FROM THE O-RINGS NOT BEING REPLACED ON THE REUSABLE TIPS. O-RINGS WILL WEAR AND MUST BE REPLACED. WORN O-RING WILL CREATE A POOR VACUUM CONDITION. THIS COMPLAINT IS NOT A MANUFACTURING ISSUE BUT IS SERVICE ISSUE THAT MUST BE PERFORMED BY THE CUSTOMER. THE DFU INSTRUCTS THE USER TO INSPECT FOR WORN O-RINGS AND TO REPLACE WHEN THEY ARE WORN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VACUUM PROBLEMS DURING IRRIGATION AND ASPIRATION (I/A) OF A PROCEDURE. THE HANDPIECE AND TIP WAS EXCHANGED TO COMPLETE SURGERY WITH NO HARM TO THE PT. UPON FURTHER EXAMINATION OF THE HANDPIECE AND TIP, IT WAS NOTED THE O RINGS NEEDED TO BE REPLACED O THE TIPS. THE O RINGS WERE REPLACED. SAMPLES ARE NOT EXPECTED AS THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235824 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ULTRA O-RING RPL