BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3093636 · Received May 1, 2013

    Report

    Report Number
    2028159-2013-00726
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLGOY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT REPLICATE THE REPORTED EVENT. THE COMPANY REPRESENTATIVE TESTED 3 PHACO HANDPIECES AT THE FACILITY WITH NO OBSERVED NONCONFORMITIES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL RELATED REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HEARING A FLUTTERING SOUND WHILE USING THE PHACO HANDPIECE DURING A CATARACT EXTRACTION PROCEDURE. THE PROCEDURE WAS CANCELLED. THERE WAS NO HARM TO THE PATIENT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189749 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLGOY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other