BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1841252 · Received September 14, 2010

    Report

    Report Number
    2023826-2010-00869
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH, CARTRIDGE LOT NUMBER SEARCH. RESULTS: A LENS WORK ORDER AND NO SIMILAR COMPLAINT WAS FOUND WITHIN SAME WORK ORDER. A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A 23.0 DIOPTER AQ2015A COLLAMER ASPHERIC THREE PIECE LENS. THE LENS TORE, IT WAS NOTICED AFTER THE LENS WAS INSERTED INTO THE PT'S EYE. LENS WAS REMOVED WITH NO PT INJURY. REPORTER STATED THE CARTRIDGE TORE THE LENS. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY AQ CARTRIDGE-FP 1253979

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR INJECTOR: MODEL - MSI-TM, LOT# - 1252818| LENS: MODEL AQ2015V, SERIAL# 4755775