BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE EMV

    MDR report key: 17432771 · Received August 1, 2023

    Report

    Report Number
    3012304651-2023-00089
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867006104
    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 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 VERY UNLIKELY. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE EMV RAO200E BATCH 062194303 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL DEVICES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. 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 062194303. RAYNER IS FOLLOWING UP VIA ITS AFFILIATE COMPANY IN FRANCE TO OBTAIN ADDITIONAL INFORMATION TO FACILITATE FURTHER INVESTIGATION OF THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, RAYNER RECEIVED NOTIFICATION FROM ITS FRENCH 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
    2343665 RAYONE EMV RAYONE EMV HQL RAYNER INTRAOCULAR LENSES LIMITED RAO200E 062194303 05029867006104

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female