BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1000710 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00242
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    December 19, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: INJECTOR LOT NUMBER SEARCH, CARTRIDGE LOT NUMBER SEARCH. RESULTS (OTHER): AN INJECTOR LOT NUMBER SEARCH WAS PERFORMED AND THREE SIMILAR COMPLAINTS WERE FOUND. A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND TWO SIMILAR COMPLAINTS WERE FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN EYEONICS LENS, BUT THE LENS TORE. THE LENS WAS REMOVED WITH NO PT INJURY. THE REPORTER STATED, IT WAS THE SURGEON'S OPINION THAT THE LIKELY CAUSE OF THE IOL DAMAGE WAS DUE TO THE MSI-PF INJECTOR AND THE FOAM TIP PLUNGER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR INJECTOR MODEL MSI-FP - LOT #1230582| CARTRIDGE MODEL MTC-60C FP - LOT #1225668