BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS

    MDR report key: 21196290 · Received January 21, 2025

    Report

    Report Number
    9612169-2025-00116
    Event Type
    Injury
    Date Received
    January 21, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MFK
    UDI-DI
    00380652413534
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. 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

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. 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

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD THE MOST TROUBLE WITH DISTANCE AND NEAR VISION. NIGHT VISION TENDS TO BE WORSE. THE PATIENT IS USING CYCLOSPORINE TWICE A DAY AND USING PRESERVATIVE FREE ARTIFICIAL TEARS 1 TO 2 TIMES AN HOUR. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859573 CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK ALCON LABORATORIES IRELAND LTD. CCWTT0 25309379 00380652413534

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention