BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE GALAXY TORIC

    MDR report key: 22849264 · Received August 20, 2025

    Report

    Report Number
    3012304651-2025-00264
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 20, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C25-1672 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE LINEAR SCRATCHES WERE OBSERVED ON THE POSTERIOR SURFACE OF THE IOL. THE LENS WAS EXPLANTED AND EXCHANGED DURING THE ORIGINAL SURGERY SESSION WITHOUT FURTHER INCIDENT. THERE WAS NO HARM OR INJURY TO THE PATIENT. "IOL REPLACEMENT OR EXTRACTION" IS LISTED IN THE "ADVERSE EVENTS" SECTION OF THE RAYONE IFU. RAYNER LENSES CAN CAUSE POSTERIOR CAPSULE FOLDS/CREASING AS A DIRECT RESULT OF THE HIGH RADIAL FORCE EXERTED ON THE CAPSULAR BAG. ADDITIONALLY, IT IS ALSO POSSIBLE TO CONSIDER DELAMINATION AND/OR SCRATCHES AS POSSIBLE CAUSES OF THE LINES PRESENT ON THE OPTIC POST IMPLANTATION. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE GALAXY TORIC RAO615X BATCH 114255231 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL DEVICES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. 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 114255231. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED IT IS NOT POSSIBLE TO ESTABLISH ROOT CAUSE.

    Description of Event or Problem · 0

    ON 13TH AUGUST 2025, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN AUSTRALIA OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE GALAXY TORIC RAO615X. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE LINEAR SCRATCHES WERE OBSERVED ON THE POSTERIOR IOL SURFACE NECESSITATING LENS EXPLANTATION AND EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296439 RAYONE GALAXY TORIC RAYONE GALAXY TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO615X 114255231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown