BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM EDGEPLUS PRONG VALVED ENTRY SYSTEM

    MDR report key: 11664092 · Received April 13, 2021

    Report

    Report Number
    MW5100771
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 12, 2021
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    MLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RETINAL SURGERY ONE PIECE OF THE BLADE OF THE ALCON EDGE PLUS BLADE VALVED ENTRY SYSTEM DETACHED AND WAS EMBEDDED IN PATIENT EYE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555722 CONSTELLATION VISION SYSTEM EDGEPLUS PRONG VALVED ENTRY SYSTEM VITRECTOMY, INSTRUMENT CUTTER MLZ ALCON RESEARCH, LLC. 8065752437 2452395H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention