BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 10218019 · Received July 1, 2020

    Report

    Report Number
    2028159-2020-00477
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 9, 2020
    Report Date
    September 15, 2020
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B.5., D.10., E.1., H.3., H.6. ND H.10. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT REPLICATE THE REPORTED ISSUE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COMPANY SERVICE REPRESENTATIVE NOTE COMMUNICATION WITH THE CUSTOMERS ON HOW TO SET THE INTRAOCULAR PRESSURE (IOP) PARAMETERS TO PREVENT THE ISSUE FROM RECURRING. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO HAVE NO PROBLEM THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH INDICATED THAT SINCE THE LAST SETTINGS MADE BY COMPANY REPRESENTATIVE, THERE HAVE BEEN NO NEW PROBLEMS AND, THEREFORE, THERE ARE NO ADDITIONAL ACTIONS EXPECTED FOR THIS EVENT.

    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 SURGEON REPORTED INTRAOCULAR PRESSURE (IOP) ISSUES WITH THE SYSTEM DURING A VITRECTOMY PROCEDURE. THERE WAS NO IOP COMPENSATION FOR SEVERAL SECONDS. THE PATIENT EXPERIENCED HYPOTONIA WHICH RESULTED IN CHOROIDAL FOLDS. THE FOLDS DISAPPEAR WHEN THE IOP RETURNS TO A NORMAL VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680981 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other