BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 2142129 · Received May 26, 2011

    Report

    Report Number
    2023826-2011-00469
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STAAR JAPAN INC.
    Product Code
    HQL
    PMA / PMN Number
    K09-0161
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: NO. THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND THE OPTIC TORN AND CUT IN HALF. TORN AT THE HAPTIC AND OPTIC JUNCTION. LENS WAS RETURNED IN LIQUID. EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. CONCLUSION: BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH, AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE REPORT STATED THE SURGEON INSERTED A CQ2015A 21.0 DIOPTER THREE PIECE LENS. THE HAPTIC WAS TORN BY THE INJECTOR UPON INSERTION INTO THE EYE. LENS WAS CUT TO REMOVE FROM THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS HQL STAAR JAPAN INC. EPIPHANY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS: MODEL CQ2015A, SERIAL NUMBER (B)(4)