BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOT AVAILABLE

    MDR report key: 3772086 · Received April 14, 2014

    Report

    Report Number
    9611165-2014-00048
    Event Type
    Other
    Date Received
    April 14, 2014
    Report Date
    April 7, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. IN ORDER TO INVESTIGATE THE REPORT OF THE LENS BECOMING DULL IN THE CENTRE, ADDITIONAL INFO ON THE PATIENT'S MEDICAL HISTORY (INCLUDING ONGOING TREATMENT) AND DETAILED INFO ON THE SURGICAL PROCEDURES THAT THE PT HAS UNDERGONE AND THE SUBSTANCES INTRODUCED INTO THE EYE DURING THESE PROCEDURES, HAS BEEN REQUESTED. RAYNER IFU'S CONTRAINDICATE ACTIVE OCULAR DISEASES (CHRONIC SEVERE UVEITIS, PROLIFERATIVE DIABETIC RETINOPATHY, CHRONIC GLAUCOMA NOT RESPONSIVE TO MEDICATION) AND CORNEAL DECOMPENSATION OR ENDOTHELIAL INSUFFICIENCY. THE HEALTHCARE PROFESSIONAL HAS BEEN ASKED TO SPECIFY THE REASON FOR DSAEK SURGERY. THE REPORTING HEALTHCARE PROFESSIONAL HYPOTHESIS IS THAT THE SF6 GAS INTERACTS WITH THE MATERIAL OF THE LENS CAUSING THE DULL EFFECT HE HAS OBSERVED IN THE CENTRE OF THE IOL. THE RESULTS OF OUR FOLLOW-UP ACTIONS WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION RECEIVED AS PROVIDED TO THE DISTRIBUTOR BY THE HEALTHCARE PROFESSIONAL STATES THAT THE CENTRE OF THE IMPLANTED LENS WAS FOUND TO BECOME "DULL" FOLLOWING DSAEK SURGERY AND INSERTION OF SF6 GAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228087 NOT AVAILABLE HQL RAYNER INTRAOCULAR LENSES LTD. NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention