BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE TORIC

    MDR report key: 19916473 · Received August 6, 2024

    Report

    Report Number
    3012304651-2024-00185
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 6, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C241517 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS DID NOT INJECT AS NORMAL. THE LENS WAS EVENTUALLY IMPLANTED; HOWEVER, THE PRELOADED INJECTOR WAS REPORTED TO HAVE SEEMINGLY SPLIT BY THE SURGEON. SURGERY WAS COMPLETED SUCCESSFULLY DURING THE ORIGINAL SURGERY SESSION WITHOUT INJURY TO THE PATIENT; HOWEVER, RAYNER HAS BEEN ADVISED THAT DEVICE REPOSITIONING TOOK PLACE AND THAT SURGERY WAS PROLONGED DUE TO THE EVENT. THE RAYONE IFU "USE OF RAYONE" SECTION "FIG 7" STATES "PRESS THE PLUNGER IN A SLOW AND CONTROLLED MANNER. IF EXCESSIVE RESISTANCE IS FELT THIS COULD INDICATE A BLOCKAGE; DISCONTINUE USE OF THE PRODUCT AND RETURN THE PRODUCT AND ALL PACKAGING TO RAYNER". THE RAYONE PRELOADED IOL INJECTION SYSTEM USE RISK ANALYSIS IDENTIFIES THE FOLLOWING AS POSSIBLE CAUSES OF "TRAPPED/ TORN LENS HAPTIC/ OPTIC DURING INSERTION"; INADEQUATE AMOUNT OF VISCOELASTIC; INADEQUATE QUALITY OF VISCOELASTIC; HAPTIC TRAPPED BY PLUNGER OVERRIDE DUE TO FAST MOTION; USER OPENS CLOSED FLAPS AND CLOSES AGAIN BEFORE USE; PLUNGER ADVANCED TOO QUICKLY, INSERTION OF VISCOELASTIC THROUGH NOZZLE LEADING TO INADEQUATE AMOUNT OF VISCOELASTIC; USER REMOVED INJECTOR FROM TRAY PRIOR TO INSERTING VISCOELASTIC, CAUSING LENS TO BE IMPROPERLY PLACED IN CARTRIDGE; USER REMOVED INJECTOR FROM TRAY PRIOR TO CLOSING CARTRIDGE, RESULTING IN CARTRIDGE NOT BEING CLIPPED PROPERLY; OPTIC EDGE TRAPPED/ DAMAGED ON CLOSURE OF CARTRIDGE, SHARP EDGE INSTRUMENTS AND DEHYDRATION OF THE LENS PRIOR TO IMPLANTATION. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE TORIC RAO610T BATCH 062318211 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 THAT THIS IS AN ISOLATED EVENT. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE TORIC RAO610T BATCH 062318211. THE EVENT INFORMATION RECEIVED IS CONSISTENT WITH THE LENS BECOMING TRAPPED IN THE INJECTOR AND THE USER CONTINUINING INJECTION AGAINST THE RECOMMENDATION OF THE IFU; HOWEVER, THE MECHANISM BY WHICH THE LENS HAS BECOME TRAPPED CANNOT BE ESTABLISHED AS THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, RAYNER RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE TORIC RAO610T. THE EVENT DESCRIPTION PROVIDED STATES THAT DURING IMPLANTATION, THE LENS DID NOT INJECT AS NORMAL. EVENTUALLY THE LENS WAS IMPLANTED; HOWEVER, THE SURGEON REPORTS THAT THE INJECTOR SEEMED TO SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770221 RAYONE TORIC RAYONE TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO610T 063218211

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female