BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1019503 · Received March 26, 2008

    Report

    Report Number
    2023826-2008-00420
    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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS INSERTING A EYEONICS CRYSTALENS WITH A FOAM TIP PLUNGER AND A TRAILING HAPTIC CAUGHT IN THE FOAM TIP AND TORE IN HALF AND THAT HAPTIC GOT CAUGHT IN THE STROMA. 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 LENS. THE SURGEON DECIDED TO IMPLANT A CRYSTALENS IN PT. SEE MANUFACTURER REPORTS 2023826-2008-00416, 2023826-2008-00417, 2023826-2008-00418 AND 2023826-2008-00429 FOR THE OTHER REPORTS.

    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 INJECTOR: MODEL MSI-PF, LOT NUMBER UNK| CARTRIDGE: MODEL MTC-FP, LOT NUMBER UNK