BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL

    MDR report key: 24039864 · Received January 12, 2026

    Report

    Report Number
    1119421-2026-00098
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    November 11, 2025
    Report Date
    March 12, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652251532
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ON INITIAL MDR THE PRODUCT CODE SHOULD HAVE BEEN A040603 INSTEAD OF A140504. 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

    A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS DID NOT SLIDE PROPERLY. HENCE THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103453 CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SY60WF 16035818 00380652251532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown