BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE EMV

    MDR report key: 22436191 · Received July 8, 2025

    Report

    Report Number
    3012304651-2025-00197
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    December 18, 2025
    Report Date
    July 8, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C25-1296 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS BROKE DURING IMPLANTATION. THE LENS WAS EXPLANTED AND EXCHANGED WITHOUT FURTHER INCIDENT DURING THE ORIGINAL SURGERY SESSION AND WITHOUT HARM OR INJURY TO THE PATIENT. "IOL REPLACEMENT OR EXTRACTION" IS LISTED IN THE "ADVERSE EVENTS" SECTION OF THE RAYONE IFU. THE DEVICE HAS NOT BEEN RETURNED. 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 072195595 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 072195595. THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE TO DETERMINE THE ROOT CAUSE OF LENS BREAKAGE DURING IMPLANTATION.

    Description of Event or Problem · 0

    ON 25TH JUNE 2025, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN INDIA OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS BROKE DURING SURGERY NECESSITATING LENS EXPLANTATION AND EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157042 RAYONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED RAO200E 072195595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown