BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 838821 · Received October 18, 2006

    Report

    Report Number
    2023826-2006-01502
    Event Type
    Malfunction
    Date Received
    October 18, 2006
    Date of Event
    July 28, 2006
    Report Date
    September 18, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    k980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON INSERTED A COMPETITOR'S LENS USING THE SFC-25 FP CARTRIDGE AND THE LENS WAS DAMAGED. THE CAUSE OF THE LENS DAMAGE WAS DUE TO THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS FOLDERS AND INJECTORS HQL STAAR SURGICAL CO. SFC-25 FP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR FOAM TIP PLUNGER MODEL FTP INDIGO, LOT NUMBER UNK| INJECTOR MODEL INDIGO-P, LOT NUMBER UNK