BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERISYSE/ARTISAN LENS

    MDR report key: 23123690 · Received September 22, 2025

    Report

    Report Number
    MW5176374
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 10, 2024
    Report Date
    September 18, 2025
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    VERISYSE / ARTISAN LENS IMPLANTS DONE CAUSED CORNEAL SWELLING AND EPITHELIAL LOSS NECESSITATING CORNEAL TRANSPLANTS IN BOTH EYES. THESE IMPLANTS WERE PLACED IN 2008. REFERENCE REPORT: MW5176375. HEALTH EFFECT CODES: 1924, 1791, 2075. DEVICE PROBLEM CODE: 4001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200556 VERISYSE/ARTISAN LENS LENS, INTRAOCULAR, PHAKIC MTA OPHTEC BV

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other| R| S