BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 13717368 · Received March 10, 2022

    Report

    Report Number
    2028159-2022-00323
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 1, 2022
    Report Date
    August 9, 2022
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657511501
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND PERFORMED A CALIBRATION TO ADDRESS THE LASER ISSUE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO ISSUE WITH THE ILLUMINATION WAS NOTED. IT WAS NOT STATED WHETHER THE CALIBRATION WAS DONE AS A CORRECTION OR A PREVENTATIVE MEASURE. A SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT/BATCH/SERIAL NUMBER WAS PERFORMED. A POTENTIALLY RELEVANT COMPLAINT WAS FOUND (PR 1942053) AND REVIEWED AS PART OF THIS INVESTIGATION. THE ROOT CAUSE OF THE REPORTED EVENT OF A LASER ISSUE IS INCONCLUSIVE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS IN RELATION TO THE REPORTED EVENT OF AN ILLUMINATION ISSUE; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. MANUFACTURE WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT AN OPHTHALMIC SURGICAL CONSOLE LASER SOCKETS WERE NOT WORKING AND CHANGE OF XENON LAMP. THE PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117979 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER TABLETOP NA 00380657511501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown