BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT AVAILABLE

    MDR report key: 3698300 · Received March 11, 2014

    Report

    Report Number
    3003563511-2014-00042
    Event Type
    Injury
    Date Received
    March 11, 2014
    Report Date
    January 21, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES THAT DEVELOPMENT OF OPACIFICATION WAS OBSERVED IN THE POST-OPERATIVE PERIOD. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00042.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146370 NOT AVAILABLE HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1