BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1120009 · Received August 14, 2008

    Report

    Report Number
    2023826-2008-01076
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 24, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A 24.0 SE/2.0 DIOPTER AA4203TF TORIC SILICONE SINGLE PIECE LENS BUT THE LENS TORE IN THE INJECTOR. THERE WAS NO PATIENT CONTACT OR INJURY. A DIFFERENT TYPE LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE TORN LENS WAS DUE TO THE INJECTOR OR CARTRIDGE. THE PATIENT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY MTC-60C FP 1192506

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS MODEL: AA4203TF| INJECTOR MODEL: MSI-PR