BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4971307 · Received August 5, 2015

    Report

    Report Number
    2028159-2015-07472
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 27, 2016
    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
    MX
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPLACED PNEUMATICS MODULE WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE SHOWED NO OBVIOUS NONCONFORMITY. THE PNEUMATICS MODULE WAS INSTALLED INTO A CALIBRATED SYSTEM AND TESTED. THE REPORTED EVENT WAS UNABLE TO BE REPLICATED. THE MODULE WAS THEN TESTED AND FOUND TO MEET ALCON SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (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).

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS REPLICATED. THE PNEUMATICS MODULE WAS REPLACED TO ADDRESS THE ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE SYSTEM WAS MANUFACTURED ON JUNE 15, 2012. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE PNEUMATICS MODULE. HOWEVER, HOW OR WHEN THE MODULE BECAME NONCONFORMING CANNOT BE DETERMINED CONCLUSIVELY AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HAVING AN INFUSION PROBLEM DURING A PROCEDURE. THE CASE WAS COMPLETED BY REBOOTING THE SYSTEM. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517296 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other