BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS

    MDR report key: 24222569 · Received January 30, 2026

    Report

    Report Number
    1119421-2026-00203
    Event Type
    Injury
    Date Received
    January 30, 2026
    Report Date
    April 11, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652413664
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

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

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN H.6. FDA PATIENT CODES (E0839) HAS BEEN REMOVED. FDA PATIENT CODES (E083803) HAS BEEN ADDED. FDA METHOD CODES (B20) HAS BEEN ADDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED FLUTTER IN THE CORNER OF EYE WITH SUDDEN MOVEMENTS, EPISODES OF CLOUDY VISION, WHICH PHYSICIAN ATTRIBUTED TO FLOATERS. THE PATIENT ALSO NOTED HALOS AT NIGHT WHILE DRIVING, ESPECIALLY WITH ONCOMING HEADLIGHTS. THESE HALOS ARE LESS SEVERE COMPARED TO PRE-SURGERY BUT REMAIN BOTHERSOME. ADDITIONAL INFORMATION WAS RECEIVED PATIENT WAS HAPPY WITH THE VISION, FLUTTERING IS STILL PRESENT. PATIENT WAS SEEKING TO CONTACT HIS SURGEON TO PROVIDE DETAILS ON SYMPTOMS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281209 CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON CCWTT0 16021898 00380652413664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other