BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE TORIC

    MDR report key: 20351164 · Received October 2, 2024

    Report

    Report Number
    3012304651-2024-00253
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 2, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT ON 9TH SEPTEMBER 2024, AFTER UNSUCCESSFUL DELIVERY OF THE RAYONE TORIC IOL DURING ORIGINAL SURGERY SESSION PERFORMED ON (B)(6) 2024 (REF. FDA MDR 3012304651-2024-00251) AN ATTEMPT WAS MADE TO INJECT THE IOL; HOWEVER, IMMEDIATELY POST IMPLANTATION THE LENS WAS OBSERVED TO BE FRACTURED, NECESSITATING ITS EXPLANTATION. DUE TO LACK OF A BACK-UP LENS, THE PATIENT WAS LEFT APHAKIC AND RE-SCHEDULED TO UNDERGO THE SURGERY ON (B)(6) 2024. IT HAS BEEN REPORTED THAT THIS SURGERY SESSION WAS ALSO UNSUCCESSFUL (SEE C24-1954 - FDA MDR). "IOL REPLACEMENT OR EXTRACTION" IS LISTED IN THE "ADVERSE EVENTS" SECTION OF THE RAYONE IFU. 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 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 073219013 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 EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE RAYONE TORIC RAO610T (JULY 2023) WAS CARRIED OUT TO DETERMINE IN ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT THREE OTHER INCIDENTS HAVE BEEN REPORTED AGAINST THE RAYONE TORIC RAO610T BATCH 073219013, ORIGINATING FROM THE SAME HEALTHCARE FACILITY IN (B)(6) ((B)(4)). IT HAS BEEN CONFIRMED BY RAYNER REPRESENTATIVE IN (B)(6) THAT FOLLOWING OCCURRENCE OF THESE EVENTS INVOLVING A SINGLE LOT NUMBER OF RAYONE TORIC RAO610T, A DEVICE FROM THE SAME BATCH WAS TESTED (TEST INJECTION PERFORMED). INJECTION WAS SUCCESSFUL, WITH NO RESISTANCE EXPERIENCED, AND WITH NO DAMAGE TO THE LENS OR TO THE INJECTOR POST INJECTION. THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE IN THIS CASE TO ESTABLISH THE CAUSE OF THE LENS DAMAGE OBSERVED ON INJECTION.

    Description of Event or Problem · 0

    ON 13TH SEPTEMBER 2024, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE TORIC RAO610T. THE EVENT DESCRIPTION PROVIDED STATES THAT ON 9TH SEPTEMBER 2024, AFTER UNSUCCESSFUL DELIVERY OF THE RAYONE TORIC IOL DURING ORIGINAL SURGERY SESSION PERFORMED ON (B)(6) 2024 (REF. FDA MDR 3012304651-2024-00251) AN ATTEMPT WAS MADE TO INJECT THE IOL; HOWEVER, IMMEDIATELY POST IMPLANTATION THE LENS WAS OBSERVED TO BE FRACTURED, NECESSITATING ITS EXPLANTATION. DUE TO LACK OF A BACK-UP LENS, THE PATIENT WAS LEFT APHAKIC AND RE-SCHEDULED TO UNDERGO THE SURGERY ON (B)(6) 2024. IT HAS BEEN REPORTED THAT THIS SURGERY SESSION WAS ALSO UNSUCCESSFUL (SEE C24-1954 - FDA MDR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915637 RAYONE TORIC RAYONE TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO610T 073219013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown