BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOT AVAILABLE

    MDR report key: 4254838 · Received November 11, 2014

    Report

    Report Number
    9611165-2014-00078
    Event Type
    Other
    Date Received
    November 11, 2014
    Report Date
    October 31, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. AT THIS TIME, NO INFORMATION OTHER THAN THAT PROVIDED HAS BEEN MADE AVAILABLE TO RAYNER. RAYNER IS LIAISING WITH THE HEALTHCARE FACILITY TO OBTAIN ADDITIONAL INFORMATION TO AID US IN THE INVESTIGATION OF THE REPORTED DEVELOPMENT OF IOL OPACIFICATION. IOL OPACIFICATION IS SAID TO HAVE BEEN OBSERVED POST DSAEK SURGERY. RAYNER IS CURRENTLY WORKING TO ASCERTAIN WHAT SUBSTANCES MAY HAVE COME INTO CONTACT WITH THE IOL DURING THIS PROCEDURE. THE PATIENT'S MEDICAL HISTORY HAS ALSO BEEN REQUESTED AS IT HAS BEEN REPORTED WITHIN LITERATURE THAT PATIENT'S WITH DIABETES ARE MORE PRE-DISPOSED TO CALCIUM BUILD UP AND BREAK DOWN OF THE NORMAL BLOOD-AQUEOUS BARRIER. ANY FOLLOW-UP INFORMATION RECEIVED WILL BE PROVIDED IN A FOLLOW-UP REPORT. THE EXPLANTED IOL WILL BE RETURNED TO RAYNER FOR ANALYSIS. ANALYSIS OF THE IOL WILL BE UNDERTAKEN BY A THIRD PARTY INDEPENDENT LABORATORY. THE IOL WILL UNDERGO STRUCTURAL AND ULTRASTRUCTURAL ANALYSIS (ALIZARIN RED STAINING, LIGHT MICROSCOPY, SCANNING ELECTRON MICROSCOPY AND ENERGY DISPERSIVE X-RAY FLUORESCENCE SPECTROSCOPY (EDX)). THE RESULTS OF THE DEVICE ANALYSIS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER IOL. THE HEALTHCARE PROFESSIONAL REPORTS THAT OPACIFICATION OF THE IOL WAS DETECTED POST DSEK SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726438 NOT AVAILABLE HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention