BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE EMV

    MDR report key: 20358595 · Received October 3, 2024

    Report

    Report Number
    3012304651-2024-00255
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 3, 2024
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867006692
    PMA / PMN Number
    PO60011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE: (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) POST-OPERATIVELY. 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. I CAN CONFIRM THAT THE RECORDS FOR THE RAYONE EMV RAO200E BATCH 073221651 SHOW THAT THE BIOBURDEN AND ENDOTOXIN RESULTS ARE WITHIN THE DEFINED LIMITS. A RAYNER MICROBIOLOGICAL CAUSE FOR THE ONSET OF POST-OPERATIVE TASS IS THEREFORE EXTREMELY UNLIKELY. RAYNER HAS BEEN ADVISED THAT THE HEALTHCARE FACILITY HAS COMPLETED THEIR OWN INTERNAL INVESTIGATION AND BELIEVES THE VISCOELASTIC IS THE CAUSE OF THE POST-OPERATIVE ONSET OF TASS IN THIS CASE.

    Description of Event or Problem · 0

    ON 4TH SEPTEMBER 2024, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103663 RAYONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED RAO200E 073221651 05029867006692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown