BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4133018 · Received September 29, 2014

    Report

    Report Number
    2028159-2014-01790
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FIELD AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. A SAMPLE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A VITRECTOMY PROCEDURE THE ILLUMINATION WAS POOR. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH POOR ILLUMINATION. AT THE END OF THE CASE THE ILLUMINATION COMPLETELY SHUT OFF. THE CASE WAS COMPLETED WITHOUT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606949 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER B NA

    Patients

    Seq Age Sex Outcome Treatment
    1