BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYONE ASPHERIC

    MDR report key: 15904467 · Received December 2, 2022

    Report

    Report Number
    3012304651-2022-00117
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 18, 2022
    Report Date
    December 2, 2022
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    UDI-DI
    05029867691515
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PATIENT UNDERWENT IOL IMPLANTATION OF A RAYONE ASPHERIC RAO600C (AS SUBJECT TO THIS REPORT) AND SUPPLEMENTARY SULCOFLEX TRIFOCAL 703F IOL (SEE MDR 3012304651-2022-00118) ON (B)(6) 2022. ONE DAY POST-OPERATIVELY THE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS). DISPOSABLE SURGICAL INSTRUMENTS WERE USED AND SURGERY WAS PERFORMED WITHOUT COMPLICATION. THE PATIENT HAS BEEN PRESCRIBED YELLOX X2 DAILY, VANCOMYCIN FORTUM INFUSIONS, HAS UNDERGONE PARS PLANA VITRECTOMY AND VITROEUS TAP (NO GERM DETECTABLE). THE HEALTHCRE FACILITY HAS CONFIRMED THAT THE PATIENT'S SYMPTOMS HAVE RESOLVED FOLLOWING TREATMENT. 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. OUR REVIEW OF ENDOTOXIN AND BIOBURDEN RECORDS FOR THE BATCH CONFIRMS THAT THE PRODUCT TESTED WITHIN ACCEPTABLE TOLERANCE OF THE RESPECTIVE LIMITS. THERE IS NO RAYNER MICROBIOLOGICAL CAUSE FOR THE ONSET OF POST-OPERATIVE TASS. THE ROOT CAUSE OF THE EVENT HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 0

    ON 29TH NOVEMBER 2022, RAYNER RECEIVED NOTIFICATION FROM AN AUSTRIAN HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT ONE DAY POST-OPERATIVELY THE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602074 RAYONE ASPHERIC RAYONE ASPHERIC HQL RAYNER INTRAOCULAR LENSES LIMITED RAO600C 082196818 05029867691515

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention