BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM

    MDR report key: 23035456 · Received September 12, 2025

    Report

    Report Number
    9612169-2025-01813
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652397353
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON AVAILABLE INFORMATION FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS MALFUNCTION. NO FURTHER REPORTS REQUIRED. CORRECTED INFORMATION WAS PROVIDED IN H.6. CORRECTION: ON INITIAL MDR THE PRODUCT CODE A2201 WAS REPORTED IN ERROR IT SHOULD HAVE BEEN A030205. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN B.5. ADDITIONAL INFORMATION WAS PROVIDED IN D,9. 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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS A PLASTIC RING THAT CAME OUT WHEN THE LENS WAS GETTING READY TO BE INJECTED.

    Description of Event or Problem · 0

    A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC WAS STARTED TO GO POSTERIOR, SO THE SURGEON DIDN'T WANT TO IMPLANT LENS. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676575 CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CCA0T0 25981753 00380652397353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown