BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE GALAXY

    MDR report key: 22105082 · Received May 29, 2025

    Report

    Report Number
    3012304651-2025-00149
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 29, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 POST-OPERATIVELY THE PATIENT PRESENTED WITH PCO. IOL IMPLANTATION WAS PERFORMED ON (B)(6) 2024 AND PCO WAS FIRST OBSERVED ON (B)(6) 2025. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO HAVE A ND:YAG CAPSULOTOMY PERFORMED. THE DEVICE IS NOT AVAILABLE FOR RETURN, THE IOL REMAINS IMPLANTED. PCO IS OFTEN REFERRED TO AS "SECONDARY CATARACT" AND IS DUE TO THE MIGRATION, PROLIFERATION AND DIFFERENTIATION OF LENS EPITHELIAL CELLS. ACCORDING TO THE AMERICAN ACADEMY OF OPHTHALMOLOGY, PCO OCCURS IN 20-50% OF PATIENTS WITHIN 2-5 YEARS OF UNDERGOING CATARACT SURGERY. POTENTIAL RISK FACTORS INCLUDE THE PRESENCE OF CONDITIONS SUCH AS DIABETES, UVEITIS, MYOTONIC DYSTROPHY, RETINITIS PIGMENTOSA AND TRAUMATIC CATARACT. THE PATIENT IN THIS CASE PRESENTED WITH PCO THREE MONTHS AFTER CATARACT SURGERY. THIS IS TOO SOON FOR TYPICAL PCO AND THIS MAY INDICATE THAT SOME OTHER CONDITION CAUSED THE ONSET OF SYMPTOMS E.G., FIBRIN REACTION. CAPSULAR BAG DISTENSION SYNDROME (CBDS); HOWEVER, THIS CANNOT BE VERIFIED. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE GALAXY RAO605G BATCH 064244168 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. THE ROOT CAUSE CANNOT BE ESTABLISHED FROM THE LIMITED EVIDENCE AND INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    ON 13TH MAY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE GALAXY RAO605G. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT PRESENTED WITH POSTERIOR CAPSULE OPACIFICATION (PCO) WHICH NECESSITATED AN ADDITIONAL SURGERY TO YAG THE LENS. NOTE: RAYONE GALAXY STUDY SUBJECT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994185 RAYONE GALAXY RAYONE GALAXY HQL RAYNER INTRAOCULAR LENSES LIMITED RAO605G 064244168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown