BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 6083197 · Received November 7, 2016

    Report

    Report Number
    2028159-2016-05011
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 19, 2016
    Report Date
    January 16, 2017
    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
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT REPLICATED. HOWEVER, A SYSTEM MESSAGE (SM) WAS CONFIRMED DURING THE EXAMINATION. THE LAMP WAS REPLACED TO RESOLVE 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 JANUARY 23, 2014. 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 LAMP. HOWEVER, DETERMINING IF THE LAMP IS NONCONFORMING OR PAST ITS RATED LIFE EXPECTANCY CANNOT BE DETERMINED CONCLUSIVELY.

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT REPLICATED. HOWEVER, A SYSTEM MESSAGE (SM) WAS CONFIRMED DURING THE EXAMINATION. THE LAMP WAS REPLACED TO RESOLVE 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 JANUARY 23, 2014. 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 LAMP. HOWEVER, DETERMINING IF THE LAMP IS NONCONFORMING OR PAST ITS RATED LIFE EXPECTANCY CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A WARNING SOUND OF OVERHEATED LAMP APPEARED BEFORE A PROCEDURE. THE EVENT OCCURRED WHEN PRIMING DURING FIBER INSERTION. THERE WAS NO PATIENT INVOLVED. THE SURGERY WAS COMPLETED WITH A BACK UP SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A WARNING SOUND OF OVERHEATED LAMP APPEARED BEFORE A PROCEDURE. THE EVENT OCCURRED WHEN PRIMING DURING FIBER INSERTION. THERE WAS NO PATIENT INVOLVED. THE SURGERY WAS COMPLETED WITH A BACK UP SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.

    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

    A HEALTHCARE PROFESSIONAL REPORTED AN ALARM OF OVERHEATED LAMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734948 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other