BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM

    MDR report key: 23438733 · Received October 31, 2025

    Report

    Report Number
    9612169-2025-02183
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    September 24, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652397353
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 PRODUCT CODES (A140801) HAS BEEN UPDATED TO A140504. ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINANT INDICATES THE USE OF HEALON AS A VISCOELASTIC WHICH IS NOT QUALIFIED FOR USE WITH THE ASSOCIATED PRODUCT. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. NO SAMPLE WAS RETURNED FOR ANALYSIS. THE COMPLAINANT STATES THE USE OF NON-QUALIFIED VISCOELASTIC. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE IOL (INTRAOCULAR LENS) AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS WEDGED IN PRIMARY INCISION AND HAD TO BE CUT OUT, INCISION MADE BIGGER AND THEN REPLACEMENT LENS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894096 CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CCA0T0 25926739 00380652397353

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention HEALON PRO.