BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 17496382 · Received August 10, 2023

    Report

    Report Number
    9612169-2023-00588
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    June 27, 2023
    Report Date
    December 26, 2023
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393706
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. INTRAOCULAR LENS (IOL) RETURNED IN THREE PIECES IN A PLASTIC SAMPLE CONTAINER. SOLUTION IS DRIED ON BOTH SURFACES OF THE OPTIC AND HAPTICS. BOTH HAPTICS ARE INTACT. THE OPTIC IS TORN/SPLIT-CUT DIVIDING THE IOL IN THREE AND SCRATCHED/MARKED-REJECTABLE WITH FIBERS AND PARTICULATE. IOL CLEANED, SOLUTION REMAINED. SENT TO THE LAB FOR FURTHER EVALUATION. THE LENS WAS VISUALLY AND MICROSCOPICALLY EXAMINED, AND THE PRESENCE OF FOREIGN MATERIAL WAS CONFIRMED. MICROSCOPIC EXAMINATION SHOWS CLEAR PARTICLES UP TO APPROXIMATELY 54¿M IN LENGTH ON THE SURFACE OF THE LENS. THE CLEAR PARTICLES WERE ISOLATED AND ANALYZED USING MICROSCOPIC FOURIER TRANSFORM INFRARED SPECTROSCOPY (MICRO FT-IR). COMPARISON OF THE CLEAR PARTICLES¿ GENERATED IR SPECTRA TO A LIBRARY OF SPECTRA FINDS THE BEST MATCH TO BE OLEAMIDE (FT-IR SPECTRA 1). THE EXACT IDENTITY IS UNKNOWN. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT. A RESIDUE WAS OBSERVED ON THE RETURNED IOL. BASED ON THE SPECTRA COMPARISON RESULTS, THE "RESIDUE" IS OLEAMIDE. THE ORIGIN OF THE MATERIAL COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE 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

    AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT THE SURGEON NOTICED A FILM OR RESIDUE ON THE LENS SURFACE WHEN IT WAS IMPLANTED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851852 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25594783 00380652393706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE.