BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2802951 · Received October 19, 2012

    Report

    Report Number
    2028159-2012-01613
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE COMPANY REP REPLACED THE FLUIDICS CONTROLLER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECS. A REVIEW OF THE SYSTEM'S EVENT LOG REVEALED NO RELATED SYSTEM MESSAGES OCCURRING ON THE REPORTED EVENT DATE. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK AT THIS TIME. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTED THAT THE EQUIPMENT DISPLAYED PROBLEMS WITH IRRIGATION AND ASPIRATION DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME EQUIPMENT WITH A DELAY OF LESS THAN 15 MINUTES. THERE WAS NO HARM TO THE PT.

    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