BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1200082 · Received October 15, 2008

    Report

    Report Number
    2023826-2008-01295
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 19, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED THE HAPTIC OF A BAUSCH & LOMB LENS WAS BENT DUE TO THE INJECTOR. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MSI-TR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL & LOT # UNK