BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE GALAXY

    MDR report key: 21251034 · Received January 28, 2025

    Report

    Report Number
    3012304651-2025-00027
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Report Date
    January 29, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867005312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C25-0108 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT FOLLOWING IMPLANTATION THERE WAS A CENTRAL LARGE POSTERIOR LINEAR SCRATCH IN THE OPTIC. THE LENS WAS EXPLANTED AND EXCHANGED. THE DEVICE HAS BEEN RETAINED AND RETURNED TO RAYNER. PRODUCT EVALUATION IS CURRENTLY PENDING. BASED ON THE LIMITED EVIDENCE AVAILABLE AT THIS TIME IT IS POSSIBLE TO CONSIDER SEVERAL SCENARIOS: SCRATCHED LENS DUE TO THE LENS GETTING CAUGHT IN THE INJECTOR, SHARP INSTRUMENTS USED TO HANDLE THE LENS DURING LOADING AND/OR AS A RESULT OR PERCEIVED SCRATCH ON THE LENS DUE TO ONE OF THE FOLLOWING FACTORS: - DECLAMATION - IN RARE CIRCUMSTANCES, DELAMINATION OF THE COATING INSIDE THE NOZZLE CAN OCCUR AS THE LENS PASSES THROUGH THE NOZZLE AND AS INJECTION IS ACHIEVED THE MATERIAL IS INTRODUCED INTO THE EYE ALONGSIDE THE LENS. TYPICALLY, IT REPLICATES THE APPEARANCE OF A CREASE, SCRATCH, OR CRACK IN THE LENS. IT IS USUALLY DETECTED IMMEDIATELY AFTER THE LENS IS IMPLANTED AND HAS NO IMPACT TO PATIENT VISUAL ACUITY. IT USUALLY DISAPPEARS SPONTANEOUSLY DURING THE POST-OPERATIVE PERIOD TOO. - CAPSULAR FOLDS MAY OCCUR AS A RESULT OF THE HIGH RADIAL FORCE EXERTED ON THE CAPSULAR BAG AS THE LENS IS INSERTED/UNFOLDS IN THE EYE OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE GALAXY RAO605G BATCH 104253309 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 RAO605G BATCH 104253309. NO DEFINITIVE ROOT CAUSE ASSESSMENT CAN BE OFFERED AT THIS TIME. INVESTIGATION IS ONGOING AND ADDITIONAL INFORMATION HAS BEEN SOUGHT FROM THE HEALTHCARE FACILITY.

    Description of Event or Problem · 0

    ON 16TH JANUARY 2025, RAYNER RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE GALAXY RAO605G. THE EVENT DESCRIPTION PROVIDED STATES THAT AFTER IMPLANTATION OF THE IOL, THERE WAS A CENTRAL LARGE POSTERIOR LINEAR SCRATCH IN THE OPTIC. NOTE: RAYONE GALAXY RAO605G IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, AS THE LENS MATERIAL IS HYDROPHILIC ACRYLIC, THE SAME AS MODELS OF RAYONE AVAILABLE IN THE US, THE EVENT IS BEING REPORTED TO US FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607392 RAYONE GALAXY RAYONE GALAXY HQL RAYNER INTRAOCULAR LENSES LIMITED 605G 104253309 05029867005312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown