BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1000715 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00240
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    November 21, 2007
    Report Date
    January 30, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT AN EYEONICS LENS BUT THE TRAILING HAPTICS STRAIGHTENED OUT IN THE CARTRIDGE DURING ADVANCEMENT OF THE LENS. THERE WAS NO PT CONTACT. THE DOCTOR DECIDED TO USE A DIFFERENT LENS. THE REPORTER STATED IT WAS THE SURGEON'S OPINION THAT THE LIKELY CAUSE OF THE IOL DAMAGE WAS DUE TO THE MSI-TF INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL CO. MSI-TF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR FOAM TIP PLUNGER MODEL AND LOT # UNK| CARTRIDGE MODEL MTC-60C FP - LOT #UNK