BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 8836684 · Received July 29, 2019

    Report

    Report Number
    2028159-2019-01391
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 11, 2019
    Report Date
    January 14, 2020
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE LOT COMPLAINT HISTORY WAS REVIEWED, THIS IS THE FIFTH COMPLAINT FOR THE FINISH GOODS LOT; HOWEVER, THE FIRST FOR THIS ISSUE FOR THIS LOT. THE DEVICE HISTORY RECORD SHOWS THE PRODUCT WAS RELEASED PER SPECIFICATIONS. A SAMPLE WAS EXPECTED FOR THIS INVESTIGATION BUT HAS NOT YET BEEN RECEIVED. IF A SAMPLE IS RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED AND THE SAMPLE EVALUATED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED AS A SAMPLE HAS NOT BEEN RECEIVED TO DATE AND THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. WITHOUT ANALYSIS OF THE SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. AS THE ROOT CAUSE IS UNKNOWN, THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT CANNOT BE DETERMINED. THE ROOT CAUSE FOR THIS COMPLAINT IS NOT KNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. CONSUMABLES MANUFACTURING MANAGEMENT HAS BEEN MADE AWARE OF THIS COMPLAINT THROUGH THE CONSUMER AFFAIRS REVIEW MEETING. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE CODE OCCURRED THE PROCEDURE. THE SYSTEM WAS RECOVERED AND PROCEDURE COMPLETED WITH NO PATIENT HARM. AFTER THE PROCEDURE, THE CASSETTE WAS REMOVED AND DETERMINED THAT BALANCED SALT SOLUTION HAD LEAKED FROM THE DRAIN PUMP¿S LOCATION. TECHNICAL SERVICES CHECKED THE FLUIDIC MODULE AND THAT THERE WAS NO PROBLEM WITH THE DRAIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633634 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION SURGICAL PROCEDURE PAK