BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE ASPHERIC

    MDR report key: 11403939 · Received March 3, 2021

    Report

    Report Number
    3012304651-2021-00014
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Report Date
    March 3, 2021
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE VERBATIM REPORT STATES THAT THE PATIENT HAS PRESENTED WITH A TASS-LIKE AC REACTION POST-OPERATIVELY. THE PATIENT IS BEING TREATED WITH INTENSIVE TOPICAL STEROIDS (PREDNISOLONE ACETATE 1%) AND THE HEALTHCARE PROFESSIONAL HAS STATED THAT HE EXPECTS THEM TO RESPOND WELL. THE HEALTHCARE PROFESSIONAL IN CORRESPONDENCE WITH RAYNER HAS STATED "I AM NOT CONVINCED THAT THE IOL HAS HAD ANYTHING TO DO WITH THE POST-OPERATIVE FINDINGS I'VE SEEN AND, IN MY VIEW, IT IS ENTIRELY POSSIBLE THAT THIS HAS OCCURRED COINCIDENTALLY". THIS IS A RARE EVENT FOR WHICH OUR LIFETIME RATE IS (B)(4) (SINCE GLOBAL PRODUCT LAUNCH OF RAO600C IN OCTOBER 2016). EVERY RAYNER LENS BATCH IS SUBJECT TO ENDOTOXIN AND BIOBURDEN TESTING PRIOR TO BEING APPROVED FOR RELEASE AND IT IS THEREFORE VERY UNLIKELY THAT THE REACTION SEEN BY THE HEALTHCARE FACILITY IS RELATED TO THE LENS. OUR ENDOTOXIN RESULTS ARE DERIVED FROM BS EN ISO 11979-08 (2017) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES PART 8 FUNDAMENTAL REQUIREMENTS. WE HAVE SET OUR OWN BIOBURDEN LIMITS INTERNALLY AS THERE IS NO STANDARD THAT PRESCRIBES ACCEPTABLE LIMITS. THE AETIOLOGY OF TASS MAY BE MULTI-FACTORIAL WITH NUMEROUS POTENTIAL CAUSES. 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. METALLIC PRECIPITATE. THE FOLLOW-UP INFORMATION RECEIVED TO DATE IDENTIFIED THAT THE HEALTHCARE FACILITY EMPLOYS SOME KIND OF WARMING PROCEDURE PRIOR TO IMPLANTATING THE LENS. WHILE THERE ARE STORAGE TEMPERATURE SPECIFICATIONS SPECIFIED IN THE IFU, THE IFU MAKES NO RECOMMENDATION TO WARM THE LENS PRIOR TO IMPLANTATION. THE WARMING PROCEDURE MAY BE A CONTRIBUTORY FACTOR TO THE ONSET OF TASS-LIKE AC REACTION. RAYNER IS CONTINUING TO COMMUNICATE WITH THE HEALTHCARE FACILITY TO GAIN ADDITIONAL INFORMATION ON THIS EVENT.

    Description of Event or Problem · 1

    ON 11TH FEBRUARY 2021, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT PRESENTED WITH A TASS-LIKE ANTERIOR CHAMBER REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301838 RAYONE ASPHERIC RAYONE ASPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO600C NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention