BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE TORIC

    MDR report key: 19869774 · Received July 31, 2024

    Report

    Report Number
    3012304651-2024-00173
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C241428 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT DURING INJECTION THE LENS GOT JAMMED IN INJECTOR AND COULD NOT BE IMPLANTED. DELIVERY OF A BACK-UP LENS ALSO FAILED (SEE C24-1429 - FDA MDR 30123034651-2024-00174) AND THE PATIENT WAS LEFT APHAKIC AS A RESULT OF THE EVENT. THE PATIENT HAS BEEN LEFT APHAKIC AND THEY ARE AWAITING A SECONDARY SURGERY SESSION. INFORMATION ON THE DATE OF THE SECONDARY SURGERY SESSION HAS NOT BEEN MADE AVAILABLE TO RAYNER. 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. THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE IN THIS CASE TO ESTABLISH THE CAUSE OF THE LENS GETTING JAMMED IN INJECTOR. IN ORDER TO FACILITATE FURTHER INVESTIGATION, RAYNER IS FOLLOWING UP VIA ITS IN-COUNTRY REPRESENTATIVES TO OBTAIN ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS BEEN RETAINED AND IS BEING RETURNED TO RAYNER FOR EVALUATION. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE TORIC RAO610T BATCH 093223900 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.

    Description of Event or Problem · 0

    ON 10TH JULY 2024, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS AFFILIATE COMPANY IN FRANCE OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE TORIC RAO610T. THE EVENT DESCRIPTION PROVIDED STATES THAT DURING INJECTION THE LENS GOT JAMMED IN INJECTOR AND COULD NOT BE IMPLANTED. DELIVERY OF A BACK-UP LENS ALSO FAILED (SEE C24-1429 - FDA MDR 30123034651-2024-00174) AND THE PATIENT WAS LEFT APHAKIC AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587820 RAYONE TORIC RAYONE TORIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO610T 093223900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown