BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1063757 · Received June 19, 2008

    Report

    Report Number
    2023826-2008-00852
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 28, 2008
    Manufacturer
    STAAR SURGICAL CO.
    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

    Additional Manufacturer Narrative · 1

    OTHER (INJECTOR TIP DAMAGED LENS).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A 05.0 DIOPTER AQ2010V SILICONE THREE PIECE LENS AND THE TRAILING HAPTIC CAUGHT IN THE INJECTOR AND TORE. THE LENS WAS REMOVED WITH NO PT INJURY AND ANOTHER SAME TYPE MODEL LENS WAS IMPLANTED. THE PT'S CURRENT CONDITION IS GOOD. THE REPORTER STATED THE CAUSE OF THE LENS WAS DUE TO THE INJECTOR TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MSI-PM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CARTRIDGE MODEL AQ CARTRIDGE-FP LOT# UNK| LENS MODEL AQ2010V