BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL

    MDR report key: 17570880 · Received August 18, 2023

    Report

    Report Number
    1119421-2023-01471
    Event Type
    Injury
    Date Received
    August 18, 2023
    Report Date
    October 20, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652396721
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TROUBLE WITH CONTRAST VISION OUTDOORS AND INDOORS. EVERYTHING WAS DARK AFTER SURGERY AND WAS UNABLE TO DRIVE AT NIGHT. THE PATIENT ALSO HAD YAG LASER. THE PATIENT SEEN SURGEON MANY TIMES WHO TOLD THAT NO PROBLEM WITH VISION AND IT WOULD IMPROVE, NOTHING WAS FOUND ON EXAM. THE SURGEON TOLD PATIENT MIGHT HAVE DRY AGE RELATED MACULAR DEGENERATION (AMD) AND PRESCRIBED GLASSES WHICH WERE NOT HELPFUL. THE PATIENT HAD 2ND OPINION AND WAS TOLD MIGHT HAVE WET AMD .THE MD SAID NO NEED FOR SHOTS AND ITS DES NOT AMD. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT VISION WAS NOT IMPROVED .THE WAVELENGTH OF BLACK CONTRAST IS AFFECTED. PATIENT HAD A CONTRAST SENSITIVITY TEST DONE WHICH WAS INCONCLUSIVE. THE PATIENT FEELS THE LENS WAS BLOCKING THE LIGHT GETTING IN TO THE EYE. THE LENS WAS ATTENUATING THE RANGE OF COLORS GETTING INTO EYES. THE LIGHT WAS NOT MAKING IT DIRECTLY INTO THE EYES. THE PATIENT WAS TESTED WITH COLOR PLATES AND COULD NOT SEE ANY OF THEM. THE CONSUMER WAS ON FIBEROPTICS. THERE ARE 2 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS OD FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171755 CLAREON ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON CC60WF 15212579 00380652396721

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other| R CARTRIDGE D| EQUATE KETOFENEQUATE ARTIFICIAL TEARS| MONARCH II FORCEPS| MONARCH IV INJECTOR| PROVISC