BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031380 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00552
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    November 19, 2007
    Report Date
    March 24, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS IS STUCK IN THE TIP OF THE CARTRIDGE AND THE CARTRIDGE IS DAMAGED. THE INJECTOR HAS NO VISIBLE DAMAGE. THE CARTRIDGE AND INJECTOR HAS CLEAR SURGICAL RESIDUE ON THEM. CONCLUSIONS: A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MFG, 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 ADVANCING A THREE PIECE COLLAMER LENS MODEL CQ2015 AND THE LENS GOT STUCK IN THE CARTRIDGE. NO PT CONTACT.

    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 CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL CQ CARTRIDGE-FP| INJECTOR MODEL MSI-PM