BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE GALAXY

    MDR report key: 22121964 · Received June 2, 2025

    Report

    Report Number
    3012304651-2025-00153
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    April 16, 2025
    Report Date
    June 2, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    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. THE RAYONE ASPHERIC RAO600C IOL WAS IMPLANTED ON (B)(6) 2025 AND PCO WAS OBSERVED FOR THE FIRST TIME ON (B)(6) 2025. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON AN UNKNOWN DATE AND AN ND: YAG CAPSULOTOMY WAS PERFORMED. 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 JUST OVER TWO 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: 064244165 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 VIGILANCE DATA CONFIRMS THIS IS AN ISOLATED EVENT. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE GALAXY RAO605G, BATCH: 064244165. THERE IS INSUFFICIENT EVIDENCE AND INFORMATION AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    ON 13TH MAY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE GALAXY RAO605G. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH POSTERIOR CAPSULE OPACIFICATION (PCO) NECESSITATING YAG CAPSULOTOMY. NOTE: RAYONE GALAXY STUDY SUBJECT ID: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27893 RAYONE GALAXY RAYONE GALAXY HQL RAYNER INTRAOCULAR LENSES LIMITED RAO605G 064244165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown