BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1436317 · Received May 14, 2009

    Report

    Report Number
    2023826-2009-00504
    Event Type
    Malfunction
    Date Received
    May 14, 2009
    Date of Event
    January 26, 2009
    Report Date
    April 15, 2009
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: LOT ORDER SEARCH. RESULTS: A LOT ORDER SEARCH WAS CONDUCTED AND THERE WAS NO SIMILAR COMPLAINTS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NOOZLE OF THE SFC-45 FP CARTRIDGE LOOKED HAZED WITH A DEW OR CONDENSATION. PROBLEM WAS NOTED WHEN THE STERILE POUCH WAS OPENED. NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL COMPANY SFC-45 FP 1239932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK