BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON TORIC IOL

    MDR report key: 23790729 · Received December 12, 2025

    Report

    Report Number
    9612169-2025-02500
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 16, 2025
    Report Date
    March 9, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652410168
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D.9., H.3., H.6., AND H.11. THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE TO THE IOL WAS OBSERVED. LENS RECEIVED BROKEN IN THREE PIECES: TWO PIECES STUCK TO THE LENS CASE LID, ONE PIECE LOOSE IN THE CARTON. SOLUTION IS DRIED ON THE IOL PIECES. ONE HAPTIC IS BROKEN AND NOT RETURNED, THE OTHER HAPTIC IS DEFORMED. THE OPTIC IS BROKEN AND SCRATCHED/MARKED-REJECTABLE. THE SAME PHOTO WAS ATTACHED TO QS 2971658 AND QS 2971716. NO CLARIFICATION WAS RECEIVED ON WHICH OF THE TWO FILES THE PHOTO IS RELATED TO. PROVIDED PHOTO SHOWS A LENS IN AN OPENED LENS CASE. THE LENS IS SPLIT-CUT DIVIDING THE LENS IN TWO. ONE SEGMENT OF THE IOL IS LOCATED IN THE LENS CASE BASE WELL, THE OTHER SEGMENT OF THE IOL IS SITTING ON THE LENS CASE LID. ONE HAPTIC APPEARS TO BE BROKEN AND NOT PRESENT. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT "AN ATTEMPT WAS MADE TO IMPLANT IT, BUT IT WAS DEFECTIVE / TORN". THE LENS WAS RETURNED CUT IN SEGMENTS. THE OBSERVED DAMAGE IS CONSISTENT WITH LENS HAVING BEEN EXPLANTED. SOLUTION IS DRIED ON THE LENS WHICH SHOWS EVIDENCE OF POSSIBLE HANDLING BY THE CUSTOMER. THE REPORTED COMPLAINT IS LACKING IN RELEVANT INFORMATION SUCH AS ASSOCIATED PRODUCTS USED TO COMPLETE A THOROUGH INVESTIGATION. DUE TO THE LACK OF INFORMATION, WE ARE UNABLE TO VERIFY IF THE IOL CONTRIBUTED TO THE EVENT. IN ADDITION TO THIS, ALL IOLS ARE 100% COSMETICALLY INSPECTED AS PER APPROVED MANUFACTURING PROCEDURES AND THE OBSERVED DAMAGED LENS WOULD NOT MEET OUR CURRENT RELEASE CRITERIA. BASED ON THESE INVESTIGATION FINDINGS, WE ARE UNABLE TO VERIFY IF THE IOL CONTRIBUTED TO THE EVENT. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. 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 FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, AN ATTEMPT WAS MADE TO IMPLANT THE LENS, BUT IT WAS DEFECTIVE / TORN. THERE WAS NO HARM TO THE PATIENT, AND A BACKUP UNIT WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105461 CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNW0T4 25921158 00380652410168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown