BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE EMV

    MDR report key: 17859608 · Received October 3, 2023

    Report

    Report Number
    3012304651-2023-00124
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Report Date
    October 3, 2023
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    0502986700622
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS PRESCRIBED TOBRAMYCINE AND DEXAMETHASONE 4 TIMES DAILY, PLUS DEXAMETHASONE OINTMENT AND SUBCONJUNCTIVAL BETHAMETASONE INJECTION. HYPOPYON IS REPORTED TO HAVE RESOLVED ON DAY 5. THE HEALTHCARE FACILITY HAS ADVISED RAYNER THAT NO FURTHER ACTION IS REQUIRED IN THIS CASE AND THAT THE PATIENT HAS NOT BEEN INJURED AS A RESULT OF THE EVENT. 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. RAYNER'S ENDOTOXIN ACCEPTABLE TOLERANCES ARE DERIVED FROM BS EN ISO 11979-08 (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. OUR PRODUCTION RECORDS CONFIRM THAT THE RESULTS FOR BIOBURDEN AND ENDOTOXIN FOR THE SUBJECT RAYONE EMV RAO200E BATCH 072196530 ARE WITHIN ACCEPTABLE TOLERANCE OF THE RESPECTIVE LIMITS. A RAYNER MICROBIOLOGICAL CAUSE FOR THE ONSET OF POST-OPERATIVE TASS IS THEREFORE EXTREMELY UNLIKELY. THE ADDITIONAL INFORMATION RECEIVED IDENTIFIES THAT THE HEALTHCARE FACILITY USES RE-USABLE SURGICAL INSTRUMENTS. AS IDENTIFIED IN PUBLISHED LITERATURE, INADEQUATE/INCOMPLETE STERILISATION CYCLES OF SURGICAL INSTRUMENTS MAY BE A CONTRIBUTORY FACTOR TO THE ONSET OF TASS IN THIS CASE. 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 EMV RAO200E BATCH 072196530. THERE IS NO FAULT OF THE RAYNER DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN FRANCE OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761205 RAYONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED RAO200E 072196530 0502986700622

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male