BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1063778 · Received June 19, 2008

    Report

    Report Number
    2023826-2008-00834
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 23, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    HAPTIC TWISTED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE HAPTIC OF A BAUSCH & LOMB LENS WAS TWISTED DURING PREPARATION FOR USE DUE TO THE MSI-PF INJECTOR. THERE WAS NO PT CONTACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CARTRIDGE MODEL AND LOT#UNK