BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL

    MDR report key: 20720561 · Received November 19, 2024

    Report

    Report Number
    1119421-2024-02246
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    September 27, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652389488
    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).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, 3 SCRATCHES NOTED ON THE IOL WHEN IMPLANTED IN THE EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE IOL WAS REMOVED FROM THE PATIENT EYE AND REPLACED DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42961 ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT20 15702351 00380652389488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE