BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1052905 · Received May 22, 2008

    Report

    Report Number
    2023826-2008-00720
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 30, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVAL. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION OF THE PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THERE WAS EVIDENCES OF CLEAR SURGICAL RESIDUE. EVAL: CARTRIDGE LOT NUMBER SEARCH. RESULTS: A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLIANT WAS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY, CARTRIDGE LOT NUMBER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THE TECHNICIAN DID NOT LIKE THE WAY A 24.0 DIOPTER AQ2003V SILICONE THREE PIECE LENS WAS LOADED. THE LENS WAS TIGHT TO ADVANCE AND THE CARTRIDGE WOULDN'T CLOSE EASILY. THERE WAS NO PT CONTACT. THE TECHNICIAN OBTAINED ANOTHER LOT NUMBER OF CARTRIDGE AND THE LENS INJECTED OK. THIS IS ONE OF TWO LENSES USED FOR THIS PT - SEE MFR REPORT# 2023826-2008-00719.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. AQ CARTRIDGE-FP 1235068

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL MSI-TM| LENS MODEL AQ2003V