BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3050543 · Received March 12, 2013

    Report

    Report Number
    2028159-2013-00439
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED EVENT. THE ULTRASOUND (U/S) CONTROLLER PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL 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 SYSTEM EVENT LOG REVEALED SEVERAL SYSTEM MESSAGES (SMS) (TUNE FAILED - HANDPIECE CURRENT IS LOW). THE SM INDICATES THAT EITHER THE HANDPIECE OR THE U/S CONTROLLER PCB, WHICH DRIVES THE HANDPIECE, IS NON-CONFORMING. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT IS SUSPECTED TO BE A NON-CONFORMING U/S CONTROLLER PCB. .

    Description of Event or Problem · 1

    A CHARGE NURSE REPORTED THE SYSTEM DID NOT RECOGNIZE THE HANDPIECES DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THEY ATTEMPTED TO SWITCH OUT THE HANDPIECE WITHOUT RESOLUTION. FOLLOW A DELAY OF LESS THAN 10 MINUTES FOR A SYSTEM CHANGE, THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104735 INFINITI VISION SYSTEM OZIL UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1