BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR

    MDR report key: 3240877 · Received July 17, 2013

    Report

    Report Number
    9611165-2013-00069
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    MSS
    PMA / PMN Number
    K062612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT DESCRIPTION RECEIVED FROM THE HEALTHCARE FACILITY STATES THAT THE DOCTOR EXPERIENCED DIFFICULTIES WITH THE PLUNGER DURING USE; HOWEVER, PROCEEDED TO CONTINUE INJECTION. THE RAYNER IFU INCLUDES THE FOLLOWING STATEMENTS "WHEN DEPRESSING THE PLUNGER TOO MUCH RESISTANCE COULD INDICATE A TRAPPED LENS" AND "IF THE IOL CAUSES A BLOCKAGE IN THE INJECTOR SYSTEM, DISCARD THE INJECTOR". OUR REVIEW OF PRODUCTION RECORDS FOR THE R-INJ-04 INJECTOR BATCH B294 SHOWED THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL INJECTORS RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MFR OF THE R-INJ-04 INJECTOR (MAY 2012) WAS CONDUCTED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE R-INJ-04 INJECTOR BATCH B294. THE RESULTS OF OUR DEVICE ANALYSIS/INSPECTION WILL BE PROVIDED IN A F/U REPORT.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION OF AN EVENT THAT OCCURRED DURING USE OF A SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR (MODEL R-INJ-04). THE EVENT DESCRIPTION PROVIDED STATES "DURING INJECTION THE DOCTOR EXPERIENCED DIFFICULTIES WITH THE PLUNGER. THE DOCTOR OBSERVED THE IOL "INSIDE THE INJECTOR PLUNGER" AND IDENTIFIED THAT IT WAS "FRAGMENTED AND SEPARATED IN FRAGMENTS"".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332795 SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR MSS - DISPOSABLE INJECTOR MSS RAYNER INTRAOCULAR LENSES LTD. R-INJ-04 B294

    Patients

    Seq Age Sex Outcome Treatment
    1