BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 23452278 · Received November 3, 2025

    Report

    Report Number
    1119421-2025-02840
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389525
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    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).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON THE LENS WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS TORN AND THE SURGERY COMPLETED WITH THE REPLACEMENT LENS. THE PATIENT RECEIVED A NEW LENS WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710495 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15823978 00380652389525

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROVISC