BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE ASPHERIC

    MDR report key: 10983612 · Received December 10, 2020

    Report

    Report Number
    3012304651-2020-00027
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Report Date
    January 29, 2021
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867691638
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT 1.5 MONTHS POST-OPERATIVELY THE LENS HAS CALCIFIED. THE PATIENT VA IS 0.6 AND THE PATIENT HAS NO VISUAL LOSS. THE HEALTHCARE FACILITY INDICATED THAT IT IS THEIR INTENTION TO TREAT CALCIFICATION, LIKELY WITH ND:YAG CAPSULOTOMY. THE INFORMATION RECEIVED INDICATES THAT THERE IS NO PLAN TO EXPLANT THE IOL AT THIS TIME. THE PATIENT MEDICAL HISTORY RECEIVED STATES THAT THE PATIENT HAS INSULIN DEPENDENT DIABETES. RAYNER HAS PREVIOUSLY BEEN ADVISED BY A MEDICAL PROFESSIONAL THAT DIABETIC PATIENTS ARE MORE PREDISPOSED TO A BREAKDOWN OF THE BLOOD-AQUEOUS BARRIER. RAYNER IFUS CONTRAINDICATE "ACTIVE OCULAR DISEASES (E.G., CHRONIC SEVERE UVEITIS, PROLIFERATIVE DIABETIC RETINOPATHY, CHRONIC GLAUCOMA NOT RESPONSIVE TO MEDICATION"). THE CASE WAS REFERRED TO A CLINICAL CONSULTANT FOR REVIEW WHO PROVIDED THE FOLLOWING FEEDBACK: "I AM NOT SURE THIS IS CALCIUM. CALCIFICATION TENDS TO OCCUR IN SMOOTH SHEETS RATHER IN DISCRETE LOCALISED AREAS LIKE THIS. IN THE ABSENCE OF SYMPTOMS I WOULD LIKELY LEAVE IT ALONE. I THINK IT IS MOST LIKELY TO BE KERATIC PRECIPITATES ON THE LENS AND YOU CAN TEST THIS THEORY BY DOING A GENTLE YAG JUST IN FRONT OF THE LENS TO AVOID LENS PITS AND THE KPS WILL DISPERSE INTO THE AC". OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE ASPHERIC RAO600C BATCH 020150075 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 ASPHERIC RAO600C (FEBRUARY 2020) WAS CARRIED OUT TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE ASPHERIC RAO600C BATCH 020150075.

    Description of Event or Problem · 0

    ON (B)(6) 2020, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS RUSSIAN DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT RETURNED 1.5 MONTHS POST-OPERATIVELY TO UNDERGO EYE SURGERY IN THEIR FELLOW EYE (OS) AND THAT THE HEALTHCARE PROFESSIONAL IDENTIFIED THAT THE LENS IN THE OD EYE WAS SHOWING CALCIFICATION.

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT 1.5 MONTHS POST-OPERATIVELY THE LENS HAS CALCIFIED. THE PATIENT VA IS 0.6 AND THE PATIENT HAS NO VISUAL LOSS. THE HEALTHCARE FACILITY INDICATED THAT IT IS THEIR INTENTION TO TREAT CALCIFICATION, LIKELY WITH ND:YAG CAPSULOTOMY. THE INFORMATION RECEIVED INDICATES THAT THERE IS NO PLAN TO EXPLANT THE IOL AT THIS TIME. THE PATIENT MEDICAL HISTORY RECEIVED STATES THAT THE PATIENT HAS INSULIN DEPENDENT DIABETES. RAYNER HAS PREVIOUSLY BEEN ADVISED BY A MEDICAL PROFESSIONAL THAT DIABETIC PATIENTS ARE MORE PREDISPOSED TO A BREAKDOWN OF THE BLOOD-AQUEOUS BARRIER. RAYNER IFUS CONTRAINDICATE "ACTIVE OCULAR DISEASES (E.G., CHRONIC SEVERE UVEITIS, PROLIFERATIVE DIABETIC RETINOPATHY, CHRONIC GLAUCOMA NOT RESPONSIVE TO MEDICATION"). WITHOUT THE ABILITY TO EXAMINE THE DEVICE IT IS NOT POSSIBLE TO CONFIRM IF THE LENS HAS CALCIFIED OR IF ANOTHER BIOLOGICAL OR CHEMICAL REACTION HAS OCCURRED. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE ASPHERIC RAO600C BATCH 020150075 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 ASPHERIC RAO600C (FEBRUARY 2020) WAS CARRIED OUT TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE ASPHERIC RAO600C BATCH 020150075.

    Description of Event or Problem · 1

    ON 8TH DECEMBER 2020, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS (B)(6) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT RETURNED 1.5 MONTHS POST-OPERATIVELY TO UNDERGO EYE SURGERY IN THEIR FELLOW EYE (OS) AND THAT THE HEALTHCARE PROFESSIONAL IDENTIFIED THAT THE LENS IN THE OD EYE WAS SHOWING CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453654 RAYONE ASPHERIC RAYONE ASPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO600C 020150075 05029867691638

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention