BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE TORIC

    MDR report key: 18823457 · Received March 3, 2024

    Report

    Report Number
    3012304651-2024-00047
    Event Type
    Malfunction
    Date Received
    March 3, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 3, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C240368 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES "SURGEON FELT A VERY STRONG RESISTANCE TO ADVANCING THE LENS FROM THE VERY BEGINNING. HE HAD TO STOP THE IMPLANTATION AND "SQUEEZE" THE LENS ONTO THE OCULAR SURFACE. THEN HE TRIED TO CONTINUE THE OPERATION, USING ANOTHER CARTRIDGE AND INJECTOR FOR IMPLANTATION. BUT THIS COULD NOT BE DONE, AS THE LENS TURNED OUT TO BE DAMAGED". THE OPERATION IS REPORTED TO HAVE ENDED WITH APHAKIA WITH NO INJURY TO THE PATIENT. THE PATIENT WILL UNDERGO LASERY SURGERY TO RESOLVE THE UNDERCORRECTION. THE DEVICE ASSOCIATED WITH THIS EVENT HAS BEEN DISCARDED BY THE HEALTHCARE FACILITY. THE "USE OF RAYONE" SECTION OF THE IFU "FIG 7" READS "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". AS PER THE IFU, USE OF THE DEVICE SHOULD HAVE BEEN DISCONTINUED AT THE POINT THAT THE "STRONG RESISTANCE" WAS FIRST FELT BY THE SURGEON.

    Description of Event or Problem · 0

    ON 15TH FEBRUARY 2024, RAYNER RECEIVED NOTIFICATION FROM ITS DISTRIBUTOR IN RUSSIA OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE TORIC RAO610T. THE EVENT DESCRIPTION PROVIDED STATES THAT "SURGEON FELT A VERY STRONG RESISTANCE TO ADVANCING THE LENS FROM THE VERY BEGINNING. HE HAD TO STOP THE IMPLANTATION AND "SQUEEZE" THE LENS ONTO THE OCULAR SURFACE. THEN HE TRIED TO CONTINUE THE OPERATION, USING ANOTHER CARTRIDGE AND INJECTOR FOR IMPLANTATION. BUT THIS COULD NOT BE DONE, AS THE LENS TURNED OUT TO BE DAMAGED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165068 RAYONE TORIC RAYONE TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO610T 083222968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown