BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1000696 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00230
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 25, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS ONE HAPTIC IS TORN OFF INTO THE OPTIC AND IS MISSING. THE OPTIC IS TORN OFF IN HALF. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. CONCLUSIONS - A MULTIFUNCTIONAL TEAM INVESTIGATION COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MFG, RELEASE TESTING, AND EVALUATION 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 A THREE PIECE COLLAMER LENS MODEL CQ2015 AND A TRAILING HAPTIC TORE OFF. THE SURGEON CUT THE LENS TO REMOVE IT WITHOUT ENLARGING THE INCISION AND A BACK UP LENS WAS INSERTED. NO PT SURGERY.

    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 CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL: MSI-TM| CARTRIDGE MODEL: CQCARTRIDGE -FP