BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3880932 · Received April 7, 2014

    Report

    Report Number
    2028159-2014-00593
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. THE COMPANY REPRESENTATIVE REPLACED THE ULTRASOUND (U/S) CONTROLLER PRINTED CIRCUIT BOARD (PCB) AS A PREVENTATIVE MEASURE. THE COMPANY REPRESENTATIVE OBSERVED THE CUSTOMER INSTALLED THE FOOTSWITCH CABLE INCORRECTLY INTO THE FOOTSWITCH AND RECONNECTED CORRECTLY. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 SIMILAR REPORTS FOR THIS SYSTEM. THE SAMPLE WAS RETURNED FOR EVALUATION. THE ULTRASOUND (U/S) CONTROLLER PRINTED CIRCUIT BOARD (PCB) WAS RECEIVED AND DID NOT REVEAL ANY VISUAL NONCONFORMITY. THE RETURNED ULTRASOUND (U/S) CONTROLLER PRINTED CIRCUIT BOARD (PCB) WAS INSTALLED INTO A CALIBRATED CATARACT SYSTEM. NO NONCONFORMITIES WERE OBSERVED UPON SYSTEM BOOT-UP. THE PHACO HANDPIECES WERE EACH CONNECTED TO THE SYSTEM AND MET ALL PRODUCT SPECIFICATIONS. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING SYSTEM ISSUES DURING SURGERY. THE CASE WAS COMPLETED AFTER REBOOTING THE SYSTEM AND A 20 MINUTE DELAY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207064 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK