BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR

    MDR report key: 2798673 · Received October 16, 2012

    Report

    Report Number
    9611165-2012-00060
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    MSS
    PMA / PMN Number
    K062612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS INCIDENT BY RAYNER INTRAOCULAR LENSES LTD. CORRECTIVE ACTION WAS TAKEN BY THE HEALTHCARE FACILITY IN THE INITIAL SURGERY SESSION. WITHIN CORRESPONDENCE WITH RAYNER THAT HEALTHCARE FACILITY STATED "SURGEON HAD TO USE A SECOND INSTRUMENT (MUSHROOM) TO GET THE LENS OUT. THE LENS IS INTACT AND SUCCESSFULLY IMPLANTED". THE SURGEON HAS CONFIRMED THAT THE EVENT DID NOT NECESSITATE ANY ADDITIONAL REMEDIAL ACTION (E.G. SUTURING) AND THAT THE PT WAS NOT INJURED AS A RESULT OF THIS EVENT. THE SURGEON DOES NOT FORESEE ANY COMPLICATIONS POST-OPERATIVELY. OUR DEVICE ANALYSIS CONCLUDED THAT "TEST RESULTS SHOW BARREL/FLAP/NOZZLE COMPONENTS OF INJECTOR ALL FUNCTIONED PERFECTLY"; HOWEVER, WAS UNABLE TO ASCERTAIN THE CAUSE OF THE REPORTED EVENT. OUR REVIEW OF PRODUCTION RECORDS FOR THE R-INJ-04 INJECTOR BATCH B035 AND T-FLEX ASPHERIC 623T INTRAOCULAR LENS BATCH 050E10974 SHOWED THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL DEVICES RELEASED FROM THESE BATCHES MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. THE R-INJ-04 INJECTOR IS AVAILABLE IN THE UNITED STATES OF AMERICA; HOWEVER, IT IS SOLD AS A STAND-ALONE PRODUCT. THE R-INJ-04 INJECTOR SUBJECT TO THIS REPORT WAS SUPPLIED IN A T-FLEX ASPHERIC 623T SYSTEM PACK. THE T-FLEX ASPHERIC 623T INTRAOCULAR LENS IN NOT AVAILABLE IN THE UNITED STATES OF AMERICA.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD RECEIVED NOTIFICATION FROM THE (B)(6) OF AN INCIDENT THAT OCCURRED DURING USE OF THE T-FLEX ASPHERIC 623T INTRAOCULAR LENS AND THE SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR (MODEL R-INJ-04). THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES "THE LENS WAS LOADED IN THE BAY AS NORMAL. THE SURGEON ADVANCED THE PLUNGER, THE LENS WAS HALF OUT, AND THE PLUNGER WOULD NOT ADVANCE ANY FURTHER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR MSS - DISPOSABLE INJECTOR MSS RAYNER INTRAOCULAR LENSES LTD. R-INJ-04 B035

    Patients

    Seq Age Sex Outcome Treatment
    1