BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-FLEX

    MDR report key: 3281942 · Received August 6, 2013

    Report

    Report Number
    3003563511-2013-00027
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF EXISTING VIGILANCE DATA WAS PERFORMED BY THE MFR OF THE M-FLEX 630F IOL, RAYNER INTRAOCULAR LENSES LIMITED. THE RESULTS OF RAYNER INTRAOCULAR LENSES LIMITED'S EXISTING VIGILANCE DATA REVIEW CAN BE FOUND BELOW. EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE M-FLEX 630F IOL (MAY 2012) WAS REVIEWED TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE M-FLEX 630F IOL BATCH (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION OF AN EVENT THAT OCCURRED DURING USE OF A M-FLEX 630F INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED TO RAYNER STATES THAT THE LENS HAPTIC GOT CAUGHT DURING INJECTION. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR REPORT 9611165-2013-00075.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369204 M-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 630F 052E37905

    Patients

    Seq Age Sex Outcome Treatment
    1