BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 6030233 · Received October 14, 2016

    Report

    Report Number
    2023826-2016-01441
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    October 7, 2015
    Report Date
    October 11, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K940593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON ATTEMPTED TO IMPLANT AN AQ5010V, THREE-PIECE COLLAMER LENS, -4.00 DIOPTER IN THE PATIENT'S EYE. THE CARTRIDGE WAS SPLIT AT THE END. THE CARTRIDGE WAS NOT SUITABLE FOR ENTRY INTO THE EYE. NO FURTHER INFORMATION AVAILABLE. SEE MFR.# 2023826-2015-01468 FOR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681438 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY AQ CARTRIDGE - FP 1330635

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INJECTOR MODEL AND LOT NUMBER UNKNOWN| LENS MODEL AQ5010V- SERIAL #(B)(4)