BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1052899 · Received May 22, 2008

    Report

    Report Number
    2023826-2008-00680
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 23, 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
    CA, 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 EVALUATED. THERE WAS TEARS IN THE OPTIC, A HAPTIC WAS TORN OFF AND A PIECE OF THE LENS WAS TORN OFF AND MISSING. ADDITIONALLY, THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. H6. EVAL CODES, METHOD: LOT ORDER SEARCH. A LOT ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND. CONCLUSION: A MULTIFUNCTIONAL LEARN INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MANUFACTURING, RELEASE TESTING, AND EVAL OF TEST RESULTS. ADDITIONALLY, THE INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A +16.0 DIOPTER CQ2015A THREE PIECE COLLAMER LENS AND THE LENS WAS TORN BY THE INJECTOR DURING INSERTION. THE LENS WAS REMOVED WITHOUT ANY PT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MSI-PM 1234854

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LENS MODEL CQ2015A| CARTRIDGE MODEL CQ-CARTRIDGE-FP