BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE GALAXY TORIC

    MDR report key: 23679117 · Received December 1, 2025

    Report

    Report Number
    3012304651-2025-00365
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 1, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C25-2325 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS RIPPED IN THE EYE WHILE COMING OUT OF THE INJECTOR. THE IOL WAS EXPLANTED AND EXCHANGED DURING THE ORIGINAL SURGERY SESSION. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO FURTHER ACTION REQUIRED. "IOL REPLACEMENT OR EXTRACTION" IS LISTED IN THE "ADVERSE EVENTS" SECTION OF THE RAYONE IFU. THE DEVICE WAS NOT AVAILABLE FOR RETURN TO RAYNER. DEVICE DISCARDED BY HEALTHCARE FACILITY. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE GALAXY TORIC RAO615X BATCH: 045268477 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED SUCCESSFULLY. A REVIEW OF VIGILANCE DATA CONFIRMS THIS IS AN ISOLATED EVENT. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE GALAXY TORIC RAO615X BATCH: 045268477. THE ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE FACILITY IDENTIFIES THAT THE INJECTOR WAS REMOVED FROM THE BLISTER TRAY PRIOR TO INSERTION OF OVD AND CLOSURE OF THE FLAPS. THIS IS A DEVIATION FROM THE IFU. THE IFU STATES THAT THE INJECTOR SHOULD REMAIN IN THE TRAY UNTIL OVD IS INSERTED AND THE FLAPS ARE SECURELY CLOSED. THE RAYONE PRELOADED IOL INJECTION SYSTEM USE RISK ANALYSIS IDENTIFIES REMOVING THE INJECTOR FROM TRAY PRIOR TO INSERTING VISCOELASTIC AS CAUSING THE LENS TO BE IMPROPERLY PLACED IN THE CARTRIDGE. ADDITIONALLY, THE USER REMOVING THE INJECTOR FROM THE TRAY PRIOR TO CLOSING THE CARTRIDGE IS IDENTIFIED AS CAUSING THE CARTRIDGE TO NOT BE CLIPPED CLOSED PROPERLY. FAILURE TO FOLLOW THE IFU IS THE LIKELY CONTRIBUTORY/CAUSATIVE FACTOR OF LENS DAMAGE IN THIS CASE.

    Description of Event or Problem · 0

    ON 10TH NOVEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN CANADA OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE GALAXY TORIC RAO615X. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS RIPPED IN THE EYE COMING OUT OF THE INJECTOR. THE IOL WAS EXPLANTED AND EXCHANGED DURING THE ORIGINAL SURGERY SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949996 RAYONE GALAXY TORIC RAYONE GALAXY TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO615X 045268477

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown