BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1033603 · Received April 24, 2008

    Report

    Report Number
    2023826-2008-00587
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 28, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED, THAT THE SURGEON WAS INSERTING A 23.0 DIOPTER SILICONE ONE PIECE LENS USING A MSI-PM INJECTOR, AND THE LENS TORE AS IT WAS PUSHED THROUGH THE INJECTOR DUE TO THE INJECTORS PLUNGER. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND WAS REPLACED, SUTURE UNK. PT'S CURRENT PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE HQL STAAR SURGICAL MSI-PM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL: AQ CARTRIDGE-FP| LOT NUMBER: UNK| LENS MODEL: AA4204VF