BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE

    MDR report key: 17903051 · Received October 10, 2023

    Report

    Report Number
    3012304651-2023-00131
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Report Date
    October 10, 2023
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE. RAYNER WAS ADVISED BY A US HEALTHCARE FACILITY THAT A PATIENT POST RAYONE IOL IMPLANTATION HAD PRESENTED WITH POSSIBLE TOXIC ANTERIOR SEGMENT SYNDROME (TASS). RAYNER HAS BEEN ADVISED BY ITS IN COUNTRY REPRESENTATIVES THAT THE HEALTHCARE PROFESSIONAL DOES NOT WISH TO OFFICIALLY REPORT THE INCIDENT AND THEREFORE FURTHER INFORMATION IS CONSIDERED UNLIKELY IN THIS CASE. 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. ALL LENSES MUST TEST WITHIN ACCEPTABLE TOLERANCE OF THE RESPECTIVE LIMITS PRIOR TO THEIR RELEASE THEREFORE A RAYNER MICROBIOLOGICAL CAUSE FOR THE ONSET OF POSTOPERATIVE TASS IS EXTREMELY UNLIKELY.

    Description of Event or Problem · 0

    ON 3RD OCTOBER 2023, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF A SUSPECTED CASE OF POST-OPERATIVE TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING IMPLANTATION OF A RAYONE IOL (MODEL UNSPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283059 RAYONE RAYONE HQL RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown