BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE ASPHERIC

    MDR report key: 20350865 · Received October 2, 2024

    Report

    Report Number
    3012304651-2024-00250
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 2, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C241951 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE LENS WAS OBSERVED TO BE SCRATCHED. THE LENS WAS EXPLANTED AND EXCHANGED DURING THE ORIGINAL SURGERY SESSION. "IOL REPLACEMENT OR EXTRACTION" IS LISTED IN THE "ADVERSE EVENTS" SECTION OF THE RAYONE IFU. THE ADDITIONAL INFORMATION RECEIVED IDENTIIFES THAT THE SURGEON EXPERIENCED RESISTANCE WHEN THE LENS WAS IN THE NOZZLE. WITHIN THE RAYONE IFU "USE OF RAYONE" SECTION "FIG 7" WE STATE "PRESS THE PLUNGER IN A SLOW AND CONTROLLED MANNER. IF EXCESSIVE RESISTANCE IS FELT THIS COULD INDICATE A BLOCKAGE; DISCONTINUE USE OF THE PRODUCT AND RETURN THE PRODUCT AND ALL PACKAGING TO RAYNER". THE RAYNER HYDROPHILIC IOL USE RISK ANALYSIS IDENTIFIES THE FOLLOWING AS POSSIBLE CAUSES OF "PHYSICAL DAMAGE TO LENS"; SHARP EDGE INSTRUMENTS USED DURING SURGICAL PROCEDURE, SURGICAL PROCEDURE: INCORRECT USE OF LENS INJECTION SYSTEM, SURGEON MISIDENTIFYING POSTERIOR CAPSULE CREASING, LENS SURFACE ABLATED BY ND:YAG OPERATOR ERROR, LENS OPTIC DAMAGE DUE TO DEHYDRATION OF LENS PRIOR TO IMPLANTATION. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE ASPHERIC RAO600C BATCH 062195119 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. A REVIEW OF EXISTING VIGILANCE DATA CONFIRMS THAT THIS IS AN ISOLATED EVENT. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE ASPHERIC RAO600C BATCH 062195119. THE DEVICE WAS NOT RETURNED TO RAYNER. THE SCRATCH ON THE LENS MAY BE ATTRIBUTABLE TO CONTINUED INJECTION AT THE POINT RESISTANCE WAS ENCOUNTERED WHEN THE LENS WAS IN THE NOZZLE; HOWEVER, THIS CANNOT BE CONFIRMED WITH THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    ON 13TH SEPTEMBER 2024, RAYNER RECEIVED NOTIFICATION FROM ITS DISTIRBUTOR IN TAIWAN OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION A SCRATCH WAS OBSERVED ON THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020365 RAYONE ASPHERIC RAYONE ASPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO600C 062195119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown