BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 22521089 · Received July 16, 2025

    Report

    Report Number
    1119421-2025-01949
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    April 23, 2025
    Report Date
    July 16, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389396
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT (TFNT30-60) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P040020). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHILE LOADING THE LENS WAS STUCK TO THE INJECTOR PLUNGER. WHEN THE SURGEON ATTEMPTED TO TAKE IT OUT FROM THE CARTRIDGE THE HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED WITH BACKUP LENS. THERE WAS NO PATIENT CONTACT AND HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540027 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15417329 00380652389396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MONARCH III, CARTRIDGE D.| MONARCH III, INJECTOR.