BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3040431 · Received April 3, 2013

    Report

    Report Number
    2028159-2013-00605
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    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
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. THE SYSTEM WAS TESTED FOR PROPER IRRIGATION AND ASPIRATION FUNCTIONS. THE REPORTED EVENT OF LACK OF IRRIGATION WAS NOT REPLICATED. UNRELATED TO THE REPORTED EVENT, A PREVENTIVE MAINTENANCE (PM) WAS ALSO PERFORMED. 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 THE STM'S EVENT LOG SHOWED NO EVIDENCE TO 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 NURSE REPORTED THAT THERE WAS NO FLUID WHEN IN QUADRANT MODE DURING A CATARACT WITHIN INTRAOCULAR LENS IMPLANT PROCEDURE. THE CASE WAS COMPLETED WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136654 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON-IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1