BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3851750 · Received April 22, 2014

    Report

    Report Number
    2028159-2014-00756
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE VISIT HAS BEEN PERFORMED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE IWTH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING POOR OR NO CUTTING. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SYSTEM WAS NOT WORKING CORRECTLY DURING A VITRECTOMY, AND THIS CAUSED THE CUTTING ISSUE. THE CASE WAS COMPLETED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243747 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER TABLETOP BA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK