BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 7161045 · Received January 3, 2018

    Report

    Report Number
    2028159-2018-00033
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 6, 2017
    Report Date
    May 3, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE SYSTEM WAS MANUFACTURED ON FEBRUARY 17, 2014. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. ACTIONS TAKEN ALCON WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. SIMILAR INCIDENTS REVIEW: A REVIEW OF COMPLAINTS WITHIN THE PAST 12 MONTHS FROM THE MONTH OF THE REPORTED COMPLAINT (B)(6) 2017 SHOWED 2 SIMILAR INCIDENTS OF ¿REFLUX ISSUE¿ WHILE USING THE SYSTEM, WHERE ROOT CAUSE REMAINS INCONCLUSIVE. THIS REPRESENTS AN OCCURRENCE LEVEL OF 2 OUT OF APPROXIMATELY 3,708,285 PAKS SOLD OVER THE 12 MONTH PERIOD. A LISTING OF THESE SIMILAR INCIDENTS IS ATTACHED. THESE OCCURRENCES ARE NOT STATISTICALLY SIGNIFICANT AND THEREFORE DO NOT INDICATE ANY ADVERSE TRENDS. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE SYSTEM WAS MANUFACTURED ON FEBRUARY 17, 2014. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2017-102283.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A IRIDECTOMY PROCEDURE THERE WAS NO REFLUX WITH THE TWO SYSTEMS. THE REPORTED EVENT TOOK PLACE DURING THE LAST CASE. ANOTHER SYSTEM WAS BROUGHT IN BUT THE SAME ISSUE OCCURRED WITH THAT SYSTEM ALSO. ADDITIONAL IN FORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3990 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other