BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOT AVAILABLE

    MDR report key: 3919544 · Received June 10, 2014

    Report

    Report Number
    9611165-2014-00057
    Event Type
    Other
    Date Received
    June 10, 2014
    Report Date
    June 2, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED HAS ALLOCATED THE REF: (B)(4) TO THIS CASE. THE IOL WAS EXPLANTED BY THE HEALTHCARE PROFESSIONAL DUE TO THE DEVELOPMENT OF OPACIFICATION. THE LENS WAS RETAINED AND HAS BEEN RETURNED TO RAYNER FOR ANALYSIS. THE LENS WILL BE SENT TO AN INDEPENDENT THIRD PARTY LABORATORY FOR ANALYSIS. THE INDEPENDENT LABORATORY ANALYSIS WILL INCLUDE STRUCTURAL AND ULTRASTRUCTURAL ANALYSIS (LIGHT MICROSCOPY, SCANNING ELECTRON MICROSCOPY AND ENERGY DISPERSIVE X-RAY FLUORESCENCE SPECTROSCOPY (EDX) ). THE RESULTS OF THE ANALYSIS PERFORMED WILL BE PROVIDED IN A F/U REPORT. IN ORDER TO FULLY INVESTIGATE THE REPORTED DEVELOPMENT OF IOL OPACIFICATION ADD'L INFO HAS BEEN REQUESTED. THE DISTRIBUTOR IS COORDINATING THE F/U ACTIVITIES WITH THE REPORTING HEALTHCARE PROFESSIONAL. THE HEALTHCARE PROFESSIONAL HAS BEEN ASKED TO PROVIDE INFO SUCH AS RELEVANT PT MEDICAL HISTORY, CONCOMITANT MEDICATIONS, INFO ON ANY ADD'L SURGICAL PROCEDURES THE PT MAY HAVE UNDERGONE SINCE CATARACT SURGERY AND A LIST OF SUBSTANCES THAT MAY HAVE COME INTO CONTACT WITH THE IOL DURING ANY SURGICAL PROCEDURES. TO DATE, NO INFO OTHER THAN THAT HAS BEEN PROVIDED TO RAYER. ANY ADD'L INFO RECEIVED BY RAYNER AND THE RESULTS OF ANY INVESTIGATION ACTIONS CARRIED OUT AFTER THIS TIME WILL BE PROVIDED IN A F/U REPORT.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE DISTRIBUTOR IN (B)(6) OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER IOL. THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE POST-OPERATIVE DEVELOPMENT OF OPACIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338721 NOT AVAILABLE HQL: INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1