BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1061019 · Received June 13, 2008

    Report

    Report Number
    2023826-2008-00808
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 20, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS ONE HAPTIC IS TORN OFF INTO THE OPTIC AND IS MISSING. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL. CONCLUSIONS - A MULTIFUNCTIONAL TEAM 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

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING AN ASPHERIC THREE PIECE COLLAMER LENS MODEL CQ2015A AND THE HAPTIC TORE. THE SURGEON CUT THE LENS TO REMOVE IT WITH NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL MSI-PM LOT#UNK| CARTRIDGE: MODEL CQCARTRIDGE-FP LOT#UNK