BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1081256 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-00976
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 26, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON INSERTED A COMPETITOR'S LENS USING THE MSI-TF INJECTOR AND THE LENS WAS RIPPED BY THE PLUNGER DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS WAS IMPLANTED.

    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 UNK Required Intervention CARTRIDGE MODEL UNK| LOT NUMBER UNK