BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE

    MDR report key: 19351456 · Received May 20, 2024

    Report

    Report Number
    3012304651-2024-00098
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Report Date
    May 20, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 ON AN UNKNOWN DATE POST-OPERATIVELY, THE PATIENT PRESENTED WITH EXTREME PCO. NO FURTHER INFORMATION BEYOND THE INITIAL EVENT DESCRIPTION HAS BEEN PROVIDED TO RAYNER. PCO DUE TO THE MIGRATION, PROLIFERATION, AND DIFFERENTIATION OF LENS EPITHELIAL CELLS (LECS) TYPICALLY OCCURS IN THE 2-5 YEARS FOLLOWING IMPLANTATION, WHILE TIME TO ONSET HAS NOT BEEN SPECIFIED, THE SUGGESTION IS THAT PCO OCCURRED FAIRLY QUICKLY AFTER CATARACT SURGERY. THIS IS INDICATIVE OF ANOTHER CONDITION SUCH AS FIBROSIS, CAPSULAR BLOCK OR FIBRIN MEMBRANE ALTHOUGH NO DEFINITE DIAGNOSIS CAN BE GIVEN DUE TO THE ABSENCE OF EVIDENCE AND INFORMATION. RAYNER HAS PREVIOUSLY BEEN ADVISED BY OUR MEDICAL CONSULTANTS THAT THERE ARE SOME CONDITIONS WHICH MAY MAKE A PATIENT MORE PRE-DISPOSED TO CERTAIN POST-OPERATIVE COMPLICATIONS - INCLUDING, BUT NOT LIMITED TO: AGE-RELATED MACULAR DEGENERATION, GLAUCOMA, CORNEAL DECOMPENSATION, ENDOTHELIAL INSUFFICIENCY, AND DIABETIC RETINOPATHY. PCO IS A RECOGNISED POST-OPERATIVE COMPLICATION AFFECTING ALL IOL MANUFACTURERS. "SECONDARY MEMBRANE", "PRECIPITATES" AND "REDUCED VISION" ARE LISTED IN THE "ADVERSE EVENTS" SECTION OF RAYNER IFUS. RAYNER IS LIASING WITH ITS DISTIRBUTOR IN THE NETHERLANDS TO OBTAIN ADDITIONAL INFORMATION TO FACILITATE FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    ON 15TH APRIL 2024, RAYNER RECEIVED NOTIFICATION FROM ITS DISTRIBUTOR IN THE NETHERLANDS OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE PRELOADED IOL (MODEL UNSPECIFIED). THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT HAS PRESENTED WITH EXTREME PCO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468848 RAYONE RAYONE HQL RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown