BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS

    MDR report key: 24147240 · Received January 22, 2026

    Report

    Report Number
    1119421-2026-00168
    Event Type
    Injury
    Date Received
    January 22, 2026
    Report Date
    April 10, 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

    CORRECTION INFORMATION WAS PROVIDED IN H.6. ON INITIAL MEDICAL DEVICE REPORT (MDR) THE FDA PATIENT CODES OF E0845 AND E0839 WAS SUBMITTED. IT SHOULD HAVE BEEN E083803. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. 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 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 REQUESTED AND RECEIVED STATING THE PATIENT WAS HAPPY WITH VISION BUT WANTED TO KNOW IF THE FLUTTERING IN CORNER WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210497 CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON CCWTT0 15870887 00380652413664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other