BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 22357484 · Received June 30, 2025

    Report

    Report Number
    1119421-2025-01779
    Event Type
    Injury
    Date Received
    June 30, 2025
    Report Date
    June 30, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT WAS NOT ABLE TO SEE WELL. PATIENT EXPERIENCED BLURRY VISION, AURAS, BALANCE ISSUES, COULD NOT FOCUS AT NEAR OR FAR, AND GLASSES DID NOT WORK ANYMORE. THE LENS EXPLANTED AND PATIENT VISION WAS FINE IN THE RIGHT EYE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234529 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention ALLERGAN REFRESH OPTIVE PFAT.