BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE TORIC

    MDR report key: 18815297 · Received March 1, 2024

    Report

    Report Number
    3012304651-2024-00041
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 8, 2024
    Report Date
    March 1, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C240339 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THIS LENS WAS OPENED AS THE BACK-UP FOR THE LENS SUBJECT TO FDA MDR 3012304651-2024-00040; HOWEVER, IT IS REPORTED THAT THIS LENS ALSO FAILED TO INJECT AND THEREFORE SURGERY HAD TO BE RECHEDULED FOR LATER THAT SAME DAY. A THIRD LENS WAS IMPLANTED SUCCESSFULLY IN A SECONDARY SURGERY PERFORMED ON THE SAME DAY. A RAYNER REPRESENTATIVE WAS IN ATTENDANCE AT THE SUCCESSFUL IMPLANTATION. THERE WAS NO HARM/INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THE RAYNER 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 REMOVES INJECTOR FROM TRAY PRIOR TO CLOSING CARTRIDGE - RESULTING IN CARTRIDGE NOT BEING CLIPPED CLOSED PROPERLY AND OPTIC EDGE TRAPPED/DAMAGED ON CLOSURE OF CARTRIDGE. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE TORIC RAO610T BATCH 0873222426 SBIOWED 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. THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE IN THIS CASE TO DETERMINE THE CAUSE OF THE LENS FAILING TO EJECT.

    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 THE INITIAL LENS IMPLANTATION FAILED TO EJECT (REF. FDA MDR 3012304651-2024-00040) AND THAT THE SECONDARY BACK-UP LENS USED ALSO FAILED TO EJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306229 RAYONE TORIC RAYONE TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO610T 083222426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown