BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR

    MDR report key: 3207327 · Received July 1, 2013

    Report

    Report Number
    9611165-2013-00049
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 23, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    MSS
    PMA / PMN Number
    K062612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS EVENT BY RAYNER INTRAOCULAR LENSES LIMITED. THE HEALTHCARE FACILITY HAS ADVISED RAYNER THAT THE LENS WAS LOADED BY THE SURGEON AND THAT PROVISC VISCOELASTIC WAS UTILISED. CORRECTIVE, REMEDIAL AND PREVENTIVE ACTION WAS TAKEN BY THE HEALTHCARE PROFESSIONAL IN THE ORIGINAL PLANNED SURGERY SESSION. THE IOL WITH THE BROKEN TRAILING HAPTIC WAS EXPLANTED AND EXCHANGED FOR A BACK-UP IOL OF THE SAME MODEL AND POWER. THE HEALTHCARE PROFESSIONAL HAS CONFIRMED THAT THE EVENT DID NOT HAVE ANY ADVERSE EFFECT TO THE PT AND DESCRIBES THE CONDITION OF THE PT POST-OPERATIVELY AS "GOOD". OUR REVIEW OF THE PRODUCTION RECORDS FOR THE R-INJ-04 INJECTOR BATCH (B)(4) SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL INJECTORS RELEASED FOR DISTRIBUTION FOR THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE R-INJ-04 INJECTOR (JULY 2012) WAS CONDUCTED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN REPORTED AGAINST THE R-INJ-04 INJECTOR BATCH (B)(4). THE HEALTHCARE FACILITY RETURNED THE R-INJ-04 INJECTOR AND ASSOCIATED IOL TO RAYNER ON (B)(6) 2013. THE RESULTS OF ANY DEVICE ANALYSIS PERFORMED AS PART OF THIS INVESTIGATION WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD REC'D NOTIFICATION FROM (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR (MODEL R-INJ-04). THE EVENT DESCRIPTION PROVIDED STATES "INJECTED LENS BUT TRAILING HAPTIC BECAME TRAPPED BETWEEN PLUNGER AND NOZZLE REQUIRING EXPLANT OF IOL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297701 SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR MSS - DISPOSABLE INJECTOR MSS RAYNER INTRAOCULAR LENSES LTD. R-INJ-04 B313

    Patients

    Seq Age Sex Outcome Treatment
    1