BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL

    MDR report key: 23110517 · Received September 22, 2025

    Report

    Report Number
    1119421-2025-02542
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    May 28, 2025
    Report Date
    October 23, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN A.1., A.2., A.3.A., B.3., B.5., H.3., H.6., AND H.11. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED BY STATING, A SCRATCH WAS OBSERVED ON THE LENS DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND NO HARM.

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS JAMMED INTO INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2595379 CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SY60WF 15950345

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male UNSPECIFIED INJECTOR.