BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE ASPHERIC

    MDR report key: 10383990 · Received August 10, 2020

    Report

    Report Number
    3012304651-2020-00016
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 10, 2020
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867691652
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE INJECTOR NOZZLE SPLIT DURING IMPLANTATION TRAPPING THE IOL TRAILING HAPTIC. THE LEADING HAPTIC AND OPTIC WERE ALREADY IN THE EYE AND THE SURGEON EXTENDED THE SIDE PORT AND FREED THE IOL FROM THE INJECTOR USING FORCEPS. THE IOL WAS IMPLANTED SUCCESSFULLY WITHOUT ANY INJURY TO THE PATIENT. RAYNER CARRY OUT 100% VISUAL AND OPTICAL INSPECTION OF ALL MANUFACTURED LENSES FOR COSMETIC AND OPTICAL DEFECTS, ANY LENS WITH A COSMETIC AND/OR OPTICAL DEFECT IS IMMEDIATELY REJECTED FROM THE BATCH. ONE PRELOADED INJECTOR FROM EVERY RAYONE BATCH MANUFACTURED IS REMOVED AS PART OF A BATCH CONTROL CHECK WHICH INCLUDES INJECTION TESTING WHEREBY INJECTION PERFORMANCE, LENS ORIENTATION AND INJECTOR/LENS CONDITION POST INJECTION IS EVALUATED. OUR RECORDS SHOW THAT ALL MANUFACTURING AND QUALITY CHECKS FOR THIS BATCH WERE CONDUCTED WITH SUCCESSFUL RESULTS. THE FOLLOWING IS A NON-EXHAUSTIVE LIST OF POSSIBLE CAUSES FOR THE NOZZLE SPLITTING DURING USE; IF PART OF THE OPTIC EDGE/HAPTIC GOT TRAPPED IN THE INJECTOR MECHANISM THIS WOULD THEN PREVENT CLEAN PASSAGE THROUGH THE NOZZLE, LEADING TO PRESSURE BUILD-UP AND COULD POTENTIALLY RESULT IN THE NOZZLE SPLITTING AS COULD 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). THERE IS CURRENTLY INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE NOZZLE SPLITTING DURING USE. RAYNER IS CONTINUING TO FOLLOW-UP WITH THE HEALTHCARE FACILITY TO OBTAIN ADDITIONAL INFORMATION TO FACILITATE FURTHER INVESTIGATION OF THE EVENT. THE HOSPITAL HAS BEEN ASKED TO CONFIRM AVAILABILITY OF PRODUCT FOR RETURN.

    Description of Event or Problem · 1

    ON 31ST JULY 2020, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(6)HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT DURING IMPLANTATION THE INJECTOR NOZZLE SPLIT TRAPPING THE IOL TRAILING HAPTIC. THE LEADING HAPTIC AND OPTIC WERE ALREADY IN THE EYE AND THE SURGEON EXTENDED THE SIDE PORT AND FREED THE IOL FROM THE INJECTOR USING FORCEPS. THE IOL WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847812 RAYONE ASPHERIC RAYONE ASPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO600C 030151136 05029867691652

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention