BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE SPHERIC

    MDR report key: 17582557 · Received August 21, 2023

    Report

    Report Number
    3012304651-2023-00103
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    May 9, 2023
    Report Date
    August 21, 2023
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867690631
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 DURING IOL IMPLANTATION, THE NOZZLE RUPTURED CAUSING THE IOL TO BECOME STUCK IN THE WOUND. THE HEALTHCARE FACILITY REPORTS THAT DESPITE THE NOZZLE SPLITTING DURING USE, THE IOL WAS IMPLANTED SUCCESSFULLY WITHOUT INJURY TO THE PATIENT. THE DEVICE WAS NOT RETURNED TO RAYNER. THERE ARE MANY FACTORS THAT MAY INFLUENCE LENS DELIVERY AND COULD CAUSE OR CONTRIBUTE TO NOZZLE SPLITS DURING USE. FROM PREVIOUS INVESTIGATIONS, WE ARE AWARE OF THE FOLLOWING POSSIBLE CAUSES (NON-EXHAUSTIVE LIST): IF PART OF THE OPTIC EDGE/HAPTIC IS TRAPPED IN THE INJECTOR MECHANISM THIS CAN PREVENT CLEAN PASSAGE THROUGH THE NOZZLE, LEADING TO PRESSURE BUILD-UP AND POTENTIALLY NOZZLE SPLITTING AS CAN FORCING A BLOCKED INJECTOR. WE ARE AWARE FROM PREVIOUS INVESTIGATIONS THAT REMOVAL OF THE INJECTOR FROM THE BLISTER TRAY PRIOR TO OVD INSERTION/FLAP CLOSURE CAN INCREASE THE LIKELIHOOD OF THE LENS GETTING TRAPPED (AS IT CAN AFFECT THE POSITION OF THE LENS WITHIN THE ROTATING CARTRIDGE), INSUFFICIENT QUANTITY/QUALITY OF OVD, NOT USING OVD AND MORE RARELY IRREGULAR COATING OF THE NOZZLE (WHICH CAN ITSELF BE AN ARTEFACT OF THE LENS GETTING TRAPPED AND THE FORCE REQUIRED TO FREE THE LENS) AND OUT OF SPEC WALL THICKNESS NOZZLE COMPONENTS. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE SPHERIC RAO100C BATCH 013207456 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. WHILE IT IS NOT POSSIBLE TO ESTABLISH ROOT CAUSE, THE MOST LIKELY SCENARIO BY WHICH THE NOZZLE HAS SPLIT IN THIS CASE IS A BUILD-UP OF PRESSURE AS A RESULT OF CONTINUED INJECTION AT THE POINT THE LENS BECAME TRAPPED. WITHIN THE "USE OF RAYONE" SECTION OF THE IFU "FIG 7" WE INCLUDE THE STATEMENT "PRESS THE PLUNGER IN A SLOW AND CONTROLLED MANNER. IF EXCESSIVE RESISTANCE IS FELT THIS COULD INDICATE A BLOCKAGE; STOP AND DISCARD THE INJECTOR AND LENS". WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED IT IS NOT POSSIBLE TO ESTABLISH ROOT CAUSE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, RAYNER RECEIVED NOTIFICATION FROM ITS DISTRIBUTOR IN TAIWAN OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE SPHERIC RAO100C. THE EVENT DESCRIPTION PROVIDED STATES THAT DURING IOL IMPLANTATION, THE NOZZLE RUPTURED CAUSING THE IOL TO BECOME STUCK IN THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578424 RAYONE SPHERIC RAYONE SPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO100C 013207456 05029867690631

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown