BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE

    MDR report key: 21761278 · Received April 3, 2025

    Report

    Report Number
    3012304651-2025-00089
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Report Date
    April 3, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C25-0489 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE IOL HAPTIC BROKE DURING INJECTION RESULTING IN A CORNEAL INJURY. NO FURTHER INFORMATION ON THE EVENT DESCRIPTION IS AVAILABLE TO RAYNER. ADDITIONAL INFORMATION IS BEING SOUGHT FROM THE HEALTHCARE FACILITY TO FACILITATE FURTHER INVESTIGATION OF THE EVENT. 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. THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE TO DETERMINE THE CAUSE OF HAPTIC BREAKAGE IN THIS CASE.

    Description of Event or Problem · 0

    ON 11TH MARCH 2025, RAYNER RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING IMPLANTATION OF A RAYONE PRELOADED IOL (MODEL UNSPECIFIED). THE EVENT DESCRIPTION PROVIDED STATES THAT DURING INJECTION THE IOL HAPTIC BROKE RESULTING IN A CORNEAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459618 RAYONE RAYONE HQL RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown