BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR

    MDR report key: 2877863 · Received December 13, 2012

    Report

    Report Number
    9611165-2012-00080
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 12, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    MSS
    PMA / PMN Number
    K062612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. VERY LIMITED INFORMATION IS AVAILABLE ON THE REPORTED EVENT. RAYNER INTRAOCULAR LENSES LIMITED CONTACTED THE (B)(4) DISTRIBUTOR TO OBTAIN ALL SALIENT DETAILS WITHOUT SUCCESS. THE HEALTHCARE PROFESSIONAL INDICATED WITHIN THEIR DISCUSSION WITH A RAYNER REPRESENTATIVE THAT DIFFICULTY HAD BEEN EXPERIENCED WITH THE R-INJ-04 INJECTOR PRIOR TO THIS EVENT. ADDITIONAL LENS LOADING TRAINING HAS BEEN RECOMMENDED. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED A FAILURE MODE AND ROOT CAUSE CANNOT BE ASCERTAINED.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM (B)(6) OF AN EVENT THAT OCCURRED DURING USE OF A SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR (MODEL R-IMJ-04). THE EVENT DESCRIPTION PROVIDED IS AS FOLLOWS "THE PLUNGER SOFT TIP CURLED UP IN THE LOADING BAY WHEN THE LENS WAS BEING PUSHED FORWARDS."

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1