BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE EMV

    MDR report key: 19916470 · Received August 6, 2024

    Report

    Report Number
    3012304651-2024-00186
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 6, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    PO60011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C241518 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS TORN DURING THE SURGERY AND AS A RESULT WAS NOT FULLY INJECTED INTO THE EYE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP LENS DURING THE ORIGINAL SURGERY SESSION. THERE WAS NO HARM/INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THE DEVICE WAS NOT RETURNED 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 EMV RAO200E BATCH 023208366 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 EMV RAO200E BATCH 023208366. THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE TO ESTABLISH THE ROOT CAUSE OF THE LENS TEARING DURING INJECTION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, RAYNER RECEIVED NOTIFICATION FROM ITS DISTRIBUTOR IN MALAYSIA OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS TORN DURING THE SURGERY AND AS A RESULT WAS NOT FULLY INJECTED INTO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662887 RAYONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED RAO200E 023208366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown