BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERISYSE/ARTISAN LENS

    MDR report key: 23405261 · Received October 28, 2025

    Report

    Report Number
    3001237787-2025-00001
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 18, 2025
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    PMA / PMN Number
    P030028
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OPHTEC BV GENERATED COMPLAINT # (B)(4) FOR THIS COMPLAINT. OPHTEC USA HAS INITIATED CONTACT WITH THE RINTITAL REPORTERS TO GATHER ADDITIONAL DETAILS REGARDING THE INCIDENT AND THE MEDICAL DEVICE INVOLVED (EMAIL SENT ON 10/16/2025).

    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
    2029146 VERISYSE/ARTISAN LENS LENS, INTRAOCULAR, PHAKIC MTA OPHTEC BV

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention