BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1008155 · Received March 6, 2008

    Report

    Report Number
    2023826-2008-00303
    Event Type
    Injury
    Date Received
    March 6, 2008
    Date of Event
    December 13, 2007
    Report Date
    February 13, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MSS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED, THAT THE SURGEON WAS INSERTING AN EYEONICS CRYSTALENS LENS USING A MICROSTAAR INJECTOR AND CARTRIDGE AND AS THE OPTIC WAS INJECTED, THERE WAS A TEAR IN THE RIGHT EDGE OF THE TRAILING HAPTIC HINGE. THE LENS WAS CUT TO BE REMOVED. THE REPORTER STATED, THAT THE PT HAD SIGNIFICANT POST OP CORNEAL EDEMA DUE TO 3 EXPLANTS. THIS WAS ONE OF THREE INCIDENTS THAT OCCURRED TO THIS SAME PT. SEE MANUFACTURER REPORT NUMBERS 2023826-2008-00305 AND 2023826-2008-00306 FOR THE OTHER REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT NUMBER UNK| CARTRIDGE MODEL UNK