BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1022255 · Received March 26, 2008

    Report

    Report Number
    2023826-2008-00450
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    January 21, 2008
    Report Date
    March 5, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - A CARTRIDGE AND INJECTOR LOT NUMBER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND THE CARTRIDGE HAS THREE SIMILAR COMPLAINTS AND THE INJECTOR HAS ONE SIMILAR COMPLAINT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS USING A EYEONICS CRYSTALENS WITH A MSI-PF INJECTOR AND A MTC-60CFP CARTRIDGE AND A HAPTIC TORE UPON INSERTION. THE SURGEON REMOVED THE LENS WITHOUT ENLARGING THE INCISION AND REPLACED IT WITH ANOTHER CRYSTALENS. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL CO. MSI-PF 1212687

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CARTRIDGE MODEL: MTC 60CFP LOT NUMBER: 1232607