BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1905573 · Received November 19, 2010

    Report

    Report Number
    2028159-2010-02252
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER CONTACTED TECHNICAL SUPPORT SERVICES (TSS) AND A REPLACEMENT PART WAS ORDERED. NO REPLACED PARTS ARE EXPECTED TO BE RETURNED TO THE FACILITY. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE VITRECTOR CONNECTOR ON THE CONSOLE WAS TIGHT FITTING WHILE SETTING UP FOR AN ANTERIOR VITRECTOMY SECONDARY TO A PC TEAR. THE STAFF WAS ABLE TO FORCE THE CONNECTION AND THE CASE WAS COMPETED. THERE WAS A 20-30 MINUTE DELAY REPORTED. ADDITIONAL INFO WAS REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention