BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 25018747 · Received April 28, 2026

    Report

    Report Number
    1119421-2026-00916
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652357722
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN H6. ON INITIAL MDR SUBMITTED THE PRODUCT CODE SHOULD BE A040603 INSTEAD OF A0201. ADDITIONAL INFORMATION WAS PROVIDED IN B2, B3, B5 AND D10 AND H.11. BASED ON AVAILABLE INFORMATION FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A MALFUNCTION PER REGULATION. NO FURTHER REPORTS REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE INCIDENT OCCURRED DURING PREPARATION OF THE IMPLANT, BEFORE INJECTION, DURING ADVANCEMENT OF THE IMPLANT. THERE WAS NO CONTACT WITH THE PATIENT¿S EYE. THE SURGERY WAS COMPLETED THE SAME DAY WITH THE REPLACEMENT LENS.

    Description of Event or Problem · 0

    A PHARMACIST REPORTED THAT THE IMPLANT BENDS IN THE INCORRECT DIRECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215364 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT00 15986317 00380652357722

    Patients

    Seq Age Sex Outcome Treatment
    1