BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE ASPHERIC

    MDR report key: 22105083 · Received May 29, 2025

    Report

    Report Number
    3012304651-2025-00151
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    February 4, 2025
    Report Date
    May 29, 2025
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867692185
    PMA / PMN Number
    PO60011
    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 POSTERIOR CAPSULE OPACIFICATION (PCO). IOL IMPLANTATION WAS PERFORMED ON (B)(6) 2024 AND PCO WAS OBSERVED FOR THE FIRST TIME (B)(6) 2025. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON AN UNKNOWN DATE POST-OPERATIVELY AND THE CAPSULE WAS YAG'D. 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 JUST SHY OF 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 CONFIRMED. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE ASPHERIC RAO600C BATCH 023208698 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 ASPHERIC RAO600C BATCH 023208698. 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 PROFESSIONAL OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT PRESENTED WITH POSTERIOR CAPSULE OPACIFICATION (PCO) NECESSITATING AN ADDITIONAL SURGERY TO YAG THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994186 RAYONE ASPHERIC RAYONE ASPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO600C 023208698 05029867692185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown