BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3518529 · Received December 6, 2013

    Report

    Report Number
    3003563511-2013-00070
    Event Type
    Injury
    Date Received
    December 6, 2013
    Report Date
    December 4, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF OPACIFICATION FOLLOWING ND: YAG CAPSULOTOMY. PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR REPORT 9611165-2013-0011 FOR FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633728 NA HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1