BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 5849517 · Received August 5, 2016

    Report

    Report Number
    2028159-2016-03408
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 11, 2016
    Report Date
    December 2, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    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 CLINICAL ANALYST HAS REVIEWED THIS FILE AND STATED THE FOLLOWING: ¿THE CUSTOMER REPORTED REFLUX WAS NOT WORKING. THERE WAS NO PATIENT HARM AND NO DELAYS IN THE PROCEDURE. THE SURGEON USED MANUAL REFLUX. THE OPERATOR¿S MANUAL INCLUDES A WARNING: GOOD CLINICAL PRACTICE DICTATES TESTING FOR ADEQUATE IRRIGATION, ASPIRATION FLOW, REFLUX, AND OPERATION AS APPLICABLE FOR EACH HANDPIECE PRIOR TO ENTERING EYE.¿ THE SYSTEM WAS EXAMINED AND NO PROBLEMS WERE FOUND. THE COMPANY SERVICE REPRESENTATIVE MODIFIED THE PARAMETERS TO MAKE IT WORK MORE EFFICIENTLY AND THE STAFF WAS INSTRUCTED ON HOW TO SET THE REFLOW. THE COMPANY SERVICE REPRESENTATIVE OBSERVED THE REFLUX IS A FUNCTION THAT IS NOT VERY OFTEN USED BY THE CUSTOMER. IN THIS CASE, THE CUSTOMER PERFORMED A MANUAL REFLUX BY BENDING THE TUBING OF THE ASPIRATION LINE. THE SYSTEM WAS THEN TESTED AND MET ALL 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. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE REFLUX FUNCTION WAS FOUND TO BE FUNCTIONAL AND NO PROBLEM COULD BE FOUND WITH THE SYSTEM. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT PRIOR TO A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE THE REFLUX WAS NOT WORKING. THE CASE WAS INITIATED AND COMPLETED USING MANUAL REFLUX. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504341 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other