BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 5275060 · Received December 8, 2015

    Report

    Report Number
    2028159-2015-09904
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Date of Event
    November 19, 2015
    Report Date
    February 29, 2016
    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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM HAS NO TONE WHEN THE LASER IS FIRED. FURTHER INFORMATION INDICATES THE REPORTED EVENT OCCURRED DURING SURGERY WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED AFTER SIGNIFICANT DELAY. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO REPLICATE THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE RESEATED THE SPEAKER. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON JULY 29, 2013. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT OF NO LASER TONE CAN BE ATTRIBUTED TO A CONTACT ISSUE WITH THE SPEAKER.THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT OF CASSETTE LEAK; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT OF THE CASSETTE LEAK COULD NOT BE ESTABLISHED AS A SAMPLE HAS NOT BEEN RECEIVED. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2015-132190

    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 HEALTH PROFESSIONAL REPORTED THAT A SYSTEM PRESENTED WITH NO LASER TONE AND A CASSETTE LEAK. THE TIMING OF THE EVENT AND PATIENT IMPACT ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804108 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other