BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3032951 · Received April 1, 2013

    Report

    Report Number
    2028159-2013-00526
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. 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 SOFTWARE UPGRADE IMPLEMENTED CHANGES TO THE SOFTWARE TO ENHANCE PRODUCT AND IMPROVE SYSTEM RELIABILITY, INCLUDING AN IMPROVED CASSETTE PRIMING SEQUENCE TO REMOVE TRAPPED AIR BUBBLES. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE CUSTOMER'S CONSUMABLE COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DEVICE HISTORY RECORD (DHR) AND LOT NUMBER HISTORY COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; FUNCTION TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS REPORTS OF BUBBLES RELATED TO THE CASSETTE CONSUMABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TROUBLE WITH SMALL AIR BUBBLES COMING INTO THE EYE TROUGH THE IRRIGATION TUBING DURING A VITRECTOMY PROCEDURE. THE SURGEON REPORTS THAT THE AIR BUBBLES REDUCED HIS VISIBILITY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132553 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER WITH LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1