BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON TORIC UV ABSORBING IOL

    MDR report key: 24322089 · Received February 12, 2026

    Report

    Report Number
    1119421-2026-00297
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652435147
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. THE LENS REMAINS IMPLANTED. THE REPORTED ISSUE COULD NOT BE VERIFIED. HOWEVER, THE ROOT CAUSE FOR THE REPORTED MISALIGNMENT OF THE AXIS MARKS WOULD BE MANUFACTURING RELATED. A CONTRIBUTING FACTOR TO THIS EVENT WAS THAT THE MILLING EQUIPMENT ALLOWED THE MILLING OPERATOR TO MANUALLY SELECT THE MILL ORIENTATION WHEN THE VISION SYSTEM COULD NOT IDENTIFY THE FILL HOLES ON THE WAFER. THE TORIC AXIS MARK MISALIGNMENT WAS DETERMINED TO BE A COSMETIC ISSUE ONLY, WITH NO FUNCTIONAL IMPACT. THE TORIC AXIS IS ALIGNED WITH THE TORIC AXIS MARKS AND IS SET BY THE MOLDING PROCESS. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER (SPHERICAL AND CYLINDER) AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. THE IFU (INSTRUCTIONS FOR USE) INSTRUCTS PRECISELY ALIGN THE AXIS MARKING INDENTATIONS ON THE TORIC IOL (INTRAOCULAR LENS) WITH THE MARKED INTENDED AXIS OF LENS PLACEMENT. INFORMATION WAS PROVIDED THAT THE SURGEON ALIGNED TO THE MARKINGS, IGNORING THE JUNCTION POSITION. THE PATIENT IS DOING WELL. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY HAD A STRANGE OCCURRENCE WHEN THEY PUT AN COMPANY TORIC LENS IN, THE 3 DOTS ON EACH SIDE DID NOT LINE UP AT ALL WITH THE HAPTIC JUNCTION. THEY WERE ALMOST 90 DEGREES AWAY (BUT NOT EXACTLY). THE PHYSICIAN DIDN¿T WANT TO PUT THE PATIENT THROUGH AN UNNECESSARY EXCHANGE, SO THEY LINED EVERYTHING UP BY TRUSTING THE 3 DOTS ON EACH SIDE AND IGNORING WHERE THE ACTUAL HAPTIC JUNCTION WAS. THEY HAD NEVER SEEN THIS BEFORE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE PATIENT SEEMED TO BE DOING FINE. EVEN THOUGH THE TORIC MARKINGS WERE GROSSLY AWAY FROM THE HAPTIC JUNCTION, THE SURGEON ALIGNED TO THE MARKINGS, IGNORING THE JUNCTION POSITION, AND THE PATIENT CONTINUED TO DO WELL. IT WAS CLEARLY A MANUFACTURING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385786 CLAREON TORIC UV ABSORBING IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CCW0T6 15577224 00380652435147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown