BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4863766 · Received June 23, 2015

    Report

    Report Number
    2028159-2015-06632
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 26, 2015
    Report Date
    October 5, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE LOT COMPLAINT HISTORY WAS REVIEWED, THIS IS THE SECOND COMPLAINT FOR THE FINISH GOODS LOT; HOWEVER, THE FIRST FOR THIS ISSUE. THE DHR SHOWS THE PRODUCT WAS RELEASED PER SPECIFICATIONS. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. A VISION CONSOLE REPRESENTING THE CURRENT SOFTWARE VERSION WAS USED TO TEST THE SAMPLE. THE SAMPLE COULD PRIME AND PASS INTRAOCULAR PRESSURE CALIBRATION SUCCESSFULLY. NO ANOMALIES WERE OBSERVED DURING PRIMING. NO SYSTEM MESSAGE CODE WAS GENERATED DURING TESTING. THE CONSOLES RECEIVED SIGNAL AMPLITUDE (RSA) VALUE ASSOCIATED WITH THE COMPLETED PRIMING SEQUENCE WAS FOUND TO BE MARGINALLY ABOVE THE CONSOLE THRESHOLD. THE CONSOLE WILL GENERATE A SYSTEM MESSAGE CODE(S) AND DISABLE IOP CONTROL IF THE RSA VALUE DECREASES BELOW THE THRESHOLD LIMIT AT ANY POINT DURING PRIMING OR SURGERY WHEN THE IOP FUNCTION IS ENABLED. THE INFUSION PRESSURE WAS MEASURED AT MULTIPLE SETPOINTS THROUGHOUT THE CONSOLE RANGE AND MET SPECIFICATIONS. THE SAMPLE PASSED THE REMAINING FUNCTIONAL AND PERFORMANCE TESTS. WHILE THE CUSTOMER¿S REPORT WAS NOT CONFIRMED DURING TESTING, THE MARGINAL RSA VALUE MEASURED DURING THE PRODUCT EVALUATION MAY RESULT IN THE CUSTOMER¿S REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE INTRAOCULAR PRESSURE CONTROL FAILED DURING A VITREORETINAL PROCEDURE. THE INTRAOCULAR PRESSURE FLUCTUATED FROM 10 TO 90 MILLIMETERS OF MERCURY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION AND PRODUCT SAMPLE HAVE BEEN REQUESTED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407198 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other