BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 7160881 · Received January 3, 2018

    Report

    Report Number
    2028159-2018-00028
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 6, 2017
    Report Date
    March 29, 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
    MD, US
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2017-103070.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE PHACO HANDPIECE SET OFF AN OCCLUSION WARNING. THE CUSTOMER DID NOT REQUEST SERVICE FOR THE SYSTEM. THE PHACO HANDPIECE SERIAL NUMBER (S/N) WAS NOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THEREFORE, MANUFACTURING INFORMATION COULD NOT BE OBTAINED. THE ASSOCIATED SYSTEM WAS MANUFACTURED ON JUNE 20, 2016. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AT THE END OF THE PROCEDURE THERE WAS A LOUD NOISE AND A WARNING OF OCCLUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6494 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other