BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE PRELOADED INJECTOR

    MDR report key: 4182109 · Received October 14, 2014

    Report

    Report Number
    3003563511-2014-00070
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    MSS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED REPORTS THE FOLLOWING INVESTIGATION FINDINGS: OUR REVIEW OF PRODUCTION RECORDS FOR THE R-INJ-09 INJECTOR BATCH V443 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL INJECTORS RELEASED FOR DISTRIBUTION FROM THIS BATCH MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE R-INJ-09 INJECTOR ((B)(4) 2013) WAS CARRIED OUT IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT, NO OTHER INCIDENTS, OR ANY TYPE, HAVE BEEN RECEIVED AGAINST THE R-INJ-09 BATCH (B)(4).

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(6) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF AN ADVANCE PRELOADED INJECTOR (MODEL: R-INJ-09). THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES THAT THE INJECTOR BECAME JAMMED DURING USE. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00070.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648743 ADVANCE PRELOADED INJECTOR MSS - DISPOSABLE INJECTOR MSS RAYNER INTRAOCULAR LENSES LIMITED R-INJ-09 V443

    Patients

    Seq Age Sex Outcome Treatment
    1