BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE EMV

    MDR report key: 17423015 · Received July 31, 2023

    Report

    Report Number
    3012304651-2023-00084
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    July 31, 2023
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867006654
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE C23608 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE VERBATIM REPORT RECEIVED STATES THAT POST-OPERATIVELY THE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE HEALTHCARE FACILITY IS REPORTED TO USE REUSABLE INSTRUMENTS EXPECT FOR DISPOSALS LIKE CANNULAS, PHACO TIPS , OVD ETC. THE SURGERY IS REPORTED AS BEING UNCOMPLICATED. THE STANDARD POST-OPERATIVE TREATMENT COURSE EMPLOYED BY THE HEALTHCARE FACILITY IS THAT ALL PATIENTS GET ANTIBIOTICS, STEROIDS , AND NSAIDS FOR 4 WEEKS STARTING 3 DAYS PRE-OP . THEY START AT QID WEEK 1 AND TAPER DOWN EACH WEEK TO QD AT WEEK 4. ( QID , TID , BID AND QD). THEY USE BROMOFENAC ( NSAID) PREDNISONE ( STEROID) AND MOXIFLOXACIN AS THE ANTIBIOTIC AND ALL THESE EVIDENTLY ARE IN ONE DROP REGIMENS. THE PATIENT IS REPORTED TO BE DOING WELL WITH THEIR VISION. 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. A RAYNER MICROBIOLOGICAL CAUSE FOR THE ONSET OF POST-OPERATIVE TASS IS THEREFORE EXTREMELY UNLIKELY.

    Description of Event or Problem · 0

    ON (B)(6) 2023, RAYNER RECEIVED NOTIFICATION FROM ITS US AFFILIATE COMPANY 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
    660650 RAYONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED RAO200E 062193401 05029867006654

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention