BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT AVAILABLE

    MDR report key: 4338214 · Received December 9, 2014

    Report

    Report Number
    9611165-2014-00083
    Event Type
    Injury
    Date Received
    December 9, 2014
    Report Date
    November 19, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RAYNER IFU'S INCLUDE THE CONTRAINDICATION "ACTIVE OCULAR DISEASES (CHRONIC SEVERE UVEITIS, PROLIFERATIVE DIABETIC RETINOPATHY, CHRONIC GLAUCOMA NOT RESPONSIVE TO MEDICATION)". THE INFO RECEIVED FROM THE HEALTHCARE FACILITY SUGGESTS THAT THE PT IS SUFFERING FROM MULTIPLE OCULAR AND OTHER HEALTH PROBLEMS (NVG, DM, RD). THE HEALTHCARE PROFESSIONAL EXPLANTED THE IOL AS A RESULT OF THE DEVELOPMENT OF IOL OPACIFICATION. THE PT IS REPORTED TO HAVE RECEIVED AN ALTERNATE IOL DURING THE EXPLANTATION PROCEDURE. THE VISION OF THE PT POST IOL EXPLANTATION IS REPORTED TO BE 0.05. THE HEALTHCARE PROFESSIONAL HAS CONFIRMED THAT THERE WAS NO INJURY TO THE PT AS A RESULT OF THE REPORTED EVENT. THE EXPLANTED IOL HAS BEEN RETURNED TO RAYNER FOR ANALYSIS. THE DEVICE ANALYSIS WILL BE UNDERTAKEN BY A THIRD PARTY INDEPENDENT LABORATORY. THE RESULTS OF THE DEVICE ANALYSIS WILL BE INCLUDED IN A FOLLOW UP REPORT. THE PT HAS HAD REPEAT BILATERAL OCULAR SURGICAL TRAUMA, WITH OCULAR INFLAMMATION OVER A PROLONGED PERIOD OF TIME. THE COMBINATION OF ENVIRONMENTAL CONDITIONS, MULTIPLE SURGICAL PROCEDURES AND PT HEALTH COULD BE CAUSATIVE FACTORS TO BE DEVELOPMENT OF OPACIFICATION IN THIS CASE.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS (B)(6) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER IOL. THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES THAT THE DEVELOPMENT OF IOL OPACIFICATION WAS OBSERVED APPROX 1 YEAR AFTER THE SILICON OIL INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792853 NOT AVAILABLE INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CRAVIT,| SINOMIN| TRIAMCINOLONE,| PREDFORTE,