BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE ASPHERIC

    MDR report key: 9711113 · Received February 14, 2020

    Report

    Report Number
    3012304651-2020-00007
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Report Date
    February 14, 2020
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C THE PATIENT PRESENTED WITH FIBRIN. THE HEALTHCARE PROFESSIONAL REPORTS THAT FIBRIN HAS RESOLVED AND THE PATIENT IS DOING WELL. MECHANICAL DAMAGE TO IRIS, OR UVEAL STRUCTURES FROM SURGICAL MANIPULATIONS OR TRAUMA, COMPLICATIONS ARISING FROM INCIDENCE OF TASS, PEX SYNDROME, DIABETES, PREVIOUS UVEITIS, PREVIOUS INTRAOCULAR SURGERY AND DIABETIC SURGERY ARE ALL IDENTIFIED AS POSSIBLE CAUSES OF "FIBRIN REACTION" WITHIN RAYNER'S RISK ANALYSIS. THE VERBATIM REPORT RECEIVED MAKES A REFERENCE TO FIBRIN PRESENTING ALMOST LIKE "SLIGHT 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. THE RAYNER SALES AGENT INTERVIEWED THE HEALTHCARE PROFESSIONAL AND ASKED WHAT HE THOUGHT MIGHT HAVE CAUSED THE POST-OPERATIVE FIBRIN. THE HEALTHCARE PROFESSIONAL IN RESPONSE SHARED THAT "IT MAY BE THAT HE GOES INTO THE AC WITH OUR TIP AND IS STRETCHING THE WOUND...HE FELT IT HAS TO DO WITH WOUND HYDRATION AND PERHAPS THE LAKE OF WATER AROUND THE INCISION IS GETTING SOME FLUID INTO THE AC CAUSING THE INFLAMMATION". THERE IS NO EVIDENCE OF ANY CAUSAL RELATION BETWEEN THE EVENT AND THE RAYNER DEVICE.

    Description of Event or Problem · 1

    ON 5TH FEBRUARY 2020, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS US AFFILIATE COMPANY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT FIBRIN REACTION WAS OBSERVED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174270 RAYONE ASPHERIC RAYONE SPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO600C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention