BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SULCOFLEX TRIFOCAL

    MDR report key: 15904705 · Received December 2, 2022

    Report

    Report Number
    3012304652-2022-00118
    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
    05029867000348
    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 (SEE MDR 3012304651-2022-00117) AND SUPPLEMENTARY SULCOFLEX TRIFOCAL 703F IOL (AS SUBJECT TO THIS REPORT) 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 VITREOUS TAP (NO GERM DETECTABLE). THE HEALTHCARE 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 SULCOFLEX TRIFOCAL 703F IOL. THE EVENT DESCRIPTION PROVIDED STATES THAT ONE DAY POST-OPERATIVELY THE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT UNDERWENT DUET SURGERY AND A RAYONE ASPHERIC RAO600C AND SULCOFLEX TRIFOCAL 703F IOL WERE IMPLANTED IN A SINGLE PROCEDURE (SEE MDR 3012304651-2022-00117 FOR DETAILS OF RAYONE ASPHERIC RAO600C LENS). NOTE: SULCOFLEX TRIFOCAL 703F IS NOT AVAILABLE IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371710 SULCOFLEX TRIFOCAL SULCOFLEX TRIFOCAL HQL RAYNER INTRAOCULAR LENSES LIMITED 703F 111178300 05029867000348

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention