BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL

    MDR report key: 22077187 · Received May 23, 2025

    Report

    Report Number
    1119421-2025-01468
    Event Type
    Injury
    Date Received
    May 23, 2025
    Report Date
    June 26, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652457347
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT ORIGINALLY FILED AS 9612169-2025-00584. 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

    CORRECTION INFORMATION WAS PROVIDED IN B.5., H.6., AND H.11. ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. CORRECTION: ON INITIAL MDR THE FDA PATIENT CODE OF E083803 WAS MISSED. IT SHOULD HAVE BEEN SUBMITTED IN THE INITIAL MDR. IN THE INITIAL MDR, THE PRODUCT CODE A030205 WAS ENTERED IN ERROR AND IS NO LONGER REQUIRED IN THE ORIGINAL MDR. THE PRODUCT WAS NOT RETURNED. 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. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE ROOT CAUSE FOR THE REPORTED EVENTS COULD NOT BE DETERMINED. THE LENS REMAINS IMPLANTED. REGARDING THE FINDINGS OF PCO, ACO, PHIMOSIS, AND IOL ROTATION OFF AXIS WITH COMPANY LENSES, A COMPANY DIRECTOR OF GLOBAL TECHNICAL CUSTOMER AFFAIRS CONSULTED WITH THE SURGEON AND PROVIDED INFORMATION RELATED TO THE REPORTED EVENTS. BECAUSE THESE FINDINGS ARE RELATED TO CLINICAL OUTCOMES, REVIEW OF COMPLAINTS FOR THE REPORTED EVENT TYPES IS THE PRIMARY INVESTIGATION FOCUS TO ASSESS FOR POTENTIAL CONCERNS RELATED TO ANTERIOR/POSTERIOR CAPSULE OPACIFICATION, PHIMOSIS, AND LENS ROTATION. INFORMATION WAS ALSO PROVIDED THAT BECAUSE CLINICAL OUTCOMES ARE COMPLEX WITH NUMEROUS POTENTIALLY ASSOCIATED CLINICAL AND SURGICAL FACTORS, ADDITIONAL INFORMATION COULD BE DISCUSSED WITH THE ACCOUNT REPRESENTATIVE, INCLUDING OPTIONS SUCH AS A PEER TO PEER COMMUNICATION SERVICE CALLED EXPERT OPINION MD, THAT COMPANY OFFERS AT NO CHARGE. REPORTS OF THESE EVENT TYPES HAVE REMAINED LOW AND STABLE, WITH INTERMITTENT REPORTING AS EXPECTED, BASED ON THE POTENTIAL MULTIFACTORIAL ETIOLOGY. AN ADDITIONAL GLOBAL REVIEW WAS CONDUCTED TO LOOK AT THE REPORTED INCIDENCE FOR EACH OF THE ABOVE OUTCOMES OVER THE PAST 3 YEARS. ALL GLOBAL COMPLAINTS ARE EVALUATED MONTHLY FOR ADVERSE TRENDING, AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THESE EVENTS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED WITH POSTERIOR CAPSULE OPACIFICATION (PCO) AND THE IOL WAS ROTATED. A GRADE 2 PCO WAS IDENTIFIED AFTER 3 MONTHS POST-OPERATIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT STATED THAT THE GRADE 2 PCO AT 3 MONTHS, IOL WAS ROTATED AXIS FROM 12 DEGREES TO 30 DEGREES, CONCERNED REGARDING THE LENS MATERIAL VERSES CARTRIDGE MATERIAL CAUSING THE LENS TO BE SLICK AND ROTATE. THE SURGEON NOTICED CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LES REQUIRING REMOVAL WITH IRRIGATION AND ASPIRATION BUT THAT CAN SOMETIMES BE DIFFICULT. . THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Description of Event or Problem · 0

    POSTOP VISIT INTERVALS THE PATIENT EXPERIENCED FLOATERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515082 CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CCWTT3 15450253 00380652457347

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention CLAREON MONARCH IV IOL , INJECTOR| DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE| MONARCH II LOADING FORCEPS| MONARCH III IOL , CARTRIDGE D