BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3190690 · Received June 21, 2013

    Report

    Report Number
    2028159-2013-01215
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE INVERTER PRINTED CIRCUIT BOARD (PCB) IN THE DISPLAY WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DISPLAY MONITOR WAS BLANK AND THEY WERE UNABLE TO USE THE SYSTEM. THE PROCEDURES SCHEDULED FOR THAT DAY WERE CANCELLED. TWO PATIENTS HAD RECEIVED ANESTHESIA BLOCK BUT THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283003 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON MANUFACTURING, LTD. INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1