BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1019508 · Received March 26, 2008

    Report

    Report Number
    2023826-2008-00419
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 3, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS INSERTING A EYCONICS CRYSTALENS WITH A MSI-PF AND A TRAILING HAPTIC CAUGHT IN THE FOAM TIP AND TORE IN HALF. THE SURGEON ENLARGED THE ORIGINAL INCISION AND CUT UP THE LENS TO REMOVE IT AND PUT IN A SUTURE. PT HAD CORNEAL EDEMA DUE TO THE FACT THAT THIS WAS ONE OF THREE ATTEMPTS TO INSERT A EYEONICS CRYSTALENS. SEE MANUFACTURER REPORTS 2023826-2008-00416, 2023826-2008-00417, 2023826-2008-00418 AND 2023826-2008-00420 FOR THE OTHER REPORTS. THE FACILITY WAS UNSURE AS TO THE EXACT CAUSE OF THE LENS DAMAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention CARTRIDGE MODEL: MTC-60CFP LOT NUMBER: UNK| INJECTOR MODEL: MSI-PF LOT NUMBER: UNK