BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1203472 · Received October 17, 2008

    Report

    Report Number
    2023826-2008-01278
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 19, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC OF A COMPETITOR'S LENS WAS BENT BY THE MSI-PF INJECTOR DURING SURGERY PREPARATION. NO PATIENT 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 UNK