BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RYAONE EMV

    MDR report key: 23987758 · Received January 7, 2026

    Report

    Report Number
    3012304651-2026-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 21, 2025
    Report Date
    January 7, 2026
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 TWO DAYS POST-OPERATIVELY, THE PATIENT REPORTED A LOSS OF VISION. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) HAS BEEN DIAGNOSED BY THE HEALTHCARE FACILITY. THE PATIENT HAS BEEN PRESCRIBED STEROIDS. THE HEALTHCARE FACILITY HAS ADVISED ADDITIONAL SURGERY MAY BE REQUIRED IF THE PATIENT IS UNRESPONSIVE TO STEROIDS. THE AETIOLOGY OF TASS MAY BE MULTI-FACTORIAL WITH NUMEROUS POTENTIAL CAUSES INCLUDING BUT NOT LIMITED TO; BACTERIAL ENDOTOXINS OR PARTICULATE CONTAMINATION OF BALANCED SALT SOLUTIONS, INTRAOCULAR IRRIGATING SOLUTIONS WITH ABNORMAL PH, OSMOLARITY OR IONIC COMPOSITION, DENATURED OPHTHALMIC VISCOSURGICAL DEVICES (OVD), INTRAOCULAR MEDICATIONS (ANTIBIOTICS IN THE IRRIGATION SOLUTIONS OR INTRACAMERAL ANTIBIOTICS),TOPICAL OINTMENTS, INADEQUATE STERILIZATION OF SURGICAL INSTRUMENTS AND TUBING, INADEQUATE FLUSHING OF INSTRUMENTS BETWEEN CASES RESULTING IN BUILD-UP OF OPHTHALMIC VISCOSURGICAL DEVICES (OVD),PRESERVATIVE AND METALLIC PRECIPITATE. EVERY BATCH OF IOLS MANUFACTURED BY RAYNER ARE TESTED FOR ENDOTOXIN AND BIOBURDEN PRIOR TO RELEASE FOR SALE. RAYNER'S ENDOTOXIN ACCEPTABLE TOLERANCES ARE DERIVED FROM BS EN ISO11979-08 (2017) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES PART 8 FUNDAMENTAL REQUIREMENTS. WE HAVE SET OUR OWN LIMITS FOR BIOBURDEN AS THERE IS NO STANDARD THAT PRESCRIBES ACCEPTABLE LIMITS. THE BATCH RECORDS CONFIRM THAT ENDOTOXIN AND BIOBURDEN RESULTS TESTED WITHIN THEIR RESPECTIVE LIMITS AND THEREFORE A RAYNER MICROBIOLOGICAL CAUSE FOR THE ONSET OF POST-OPERATIVE TASS IS EXTREMELY UNLIKELY. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE EMV RAO200E BATCH 013206750 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. A REVIEW OF VIGILANCE DATA CONFIRMS THIS IS AN ISOLATED EVENT. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE EMV RAO200E BATCH 013206750. CAUSE TRACED TO NON-DEVICE RELATED FACTORS.

    Description of Event or Problem · 0

    ON 24TH DECEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN INDIA OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT TWO DAYS POST-OPERATIVELY, THE PATIENT REPORTED A LOSS OF VISION. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) HAS BEEN DIAGNOSED BY THE HEALTHCARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51948 RYAONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown