BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL

    MDR report key: 22716444 · Received August 5, 2025

    Report

    Report Number
    9612169-2025-01546
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652468381
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H.3., H.6., AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ONLY PHOTO WAS RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED FROM THE RETURNED PHOTO. A PRODUCT HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE IOL (INTRAOCULAR LENS) PRESENTATIONS IN THE TWO-DIMENSIONAL PHOTOGRAPHS ABOVE AND THE INFORMATION STATED IN THE INITIAL REPORT DESCRIPTION, IT REMAINS UNCLEAR WHICH SPECIFIC FEATURES THE REPORTER IS REFERENCING. IF THE INTENT IS TO HIGHLIGHT THE ANTERIOR IOL SURFACE WITHIN THE ILLUMINATED SLIT BEAM AREA, THE OBSERVED WHITE APPEARANCE MAY SUGGEST SUBSURFACE NANOGLISTENINGS (SSNGS). HOWEVER, DUE TO THE LIMITED CLARITY OF THE IMAGES, THIS POSSIBILITY CANNOT BE CONFIRMED. ADDITIONAL SUPPORT, SUCH AS HIGHER-RESOLUTION PHOTOGRAPHS, RETROILLUMINATION IMAGES FROM THE FUNDUS, AND MORE DETAILED INFORMATION IDENTIFYING AND DESCRIBING THE SPECIFIC FINDING(S) IN QUESTION, WOULD BE HELPFUL TO ACCURATELY IDENTIFY THE REPORTED WHITE IOL APPEARANCE, AND DETERMINE THE SIGNIFICANCE OF THE PHOTOGRAPHS WITHIN THE CONTEXT OF THE COMPLAINT INVESTIGATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED FROM THE PROVIDED PHOTOS. A DEFINITIVE DETERMINATION OF THE REPORTED COMPLAINT CANNOT BE MADE WITHOUT THE EVALUATION OF THE PHYSICAL PRODUCT. A FINAL ROOT CAUSE CANNOT BE DETERMINED BASED ON AVAILABLE INFORMATION 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 HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SSNG (SUB SURFACE NANO GLISTENINGS) OCCURRED DUE TO WHITE APPEARANCE OF THE IOL THREE YEARS AFTER SURGERY. THE LENS STILL REMAINED IN THE PATIENT'S EYE. THERE WERE NO PROBLEMS OCCURRED WITH THE PATIENT'S VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2634746 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWTT3 25227236 00380652468381

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| MONARCH III IOL DELIVERY SYSTEM, INJECTOR