BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 6188010 · Received December 19, 2016

    Report

    Report Number
    2028159-2016-05828
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 24, 2016
    Report Date
    January 24, 2017
    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
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT SHOWS THAT THE ORDER WAS BUILT TO SPECIFICATION. A SAMPLE HAS NOT BEEN RETURNED FOR THIS COMPLAINT; THEREFORE, VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED AS A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED POOR ASPIRATION DURING THE PHACO PORTION OF AN EYE SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION AND PRODUCT SAMPLE HAVE BEEN REQUESTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835943 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CENTURION PACK| CUSTOM PACK| VISCOELASTIC