BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR

    MDR report key: 2938942 · Received January 29, 2013

    Report

    Report Number
    9611165-2013-00005
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 2, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    MSS
    PMA / PMN Number
    K062612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) WAS ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. THE HEALTHCARE FACILITY IMPLANTED A BACK-UP LENS OF THE SAME MODEL AND POWER WITHOUT FURTHER COMPLICATION IN THE ORIGINAL PLANNED SURGERY SESSION. OUR REVIEW OF THE PRODUCTION RECORDS FOR THE R-INJ-04 INJECTOR BATCH B027 AND ASSOCIATED SULCOFLEX MULTIFOCAL 653F INTRAOCULAR LENS BATCH 080E11173 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL DEVICES RELEASED FOR DISTRIBUTION FOR THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED A FAILURE MODE AND ROOT CAUSE CANNOT BE ASCERTAINED. THE R-INJ-04 INJECTOR SUBJECT TO THIS REPORT WAS SUPPLIED AS PART OF A SYSTEM PACK. THE R-INJ-04 INJECTOR IS AVAILABLE IN THE UNITED STATES OF AMERICA; HOWEVER, IS ONLY SUPPLIED AS A STAND-ALONE DEVICE. THE SULCOFLEX MULTIFOCAL 653F INTRAOCULAR LENS IS NOT AVAILABLE IN THE UNITED STATES OF AMERICA.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD REC'D NOTIFICATION OF AN EVENT THAT OCCURRED DURING USE OF A SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR (MODEL R-INJ-04). THE EVENT DESCRIPTION PROVIDED INDICATES THAT THE INJECTOR FAILED TO RELEASE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38825 SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR MSS - DISPOSABLE INJECTOR MSS RAYNER INTRAOCULAR LENSES LTD. R-INJ-04 B027

    Patients

    Seq Age Sex Outcome Treatment
    1