BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 7822425 · Received August 28, 2018

    Report

    Report Number
    2028159-2018-01798
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    July 31, 2018
    Report Date
    December 7, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO REPLICATE THE REPORTED EVENT. THE NONCONFORMING MULTIFUNCTIONAL IN-OUTPUT (MFIO) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE NONCONFORMING MULTIFUNCTIONAL IN-OUTPUT (MFIO) PRINTED CIRCUIT BOARD (PCB) WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE FOUND NO NONCONFORMITIES. WHEN CHECKING THE LMZ COMPONENTS FOR SHORT CIRCUITS, A NONCONFORMING COMPONENT (U11) WAS DISCOVERED. THE SYSTEM WAS MANUFACTURED ON JANUARY 16, 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 THAT THE NONCONFORMING COMPONENTS IN THE MFIO PCB, WHICH ARE UNABLE TO SURVIVE A CONVECTION REFLOW PROCESS DESIGNED FOR THE SOLDER PASTE. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT BEFORE SURGERY, THE SYSTEM SHUT DOWN ON ITS OWN. THE SYSTEM WAS SWITCHED OUT TO PROCEED WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666112 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other