BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1081249 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-00972
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 25, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES, RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE OPTIC WAS TORN AND A HAPTIC WAS TORN OFF FROM THE OPTIC AND DEFORMED. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. CONCLUSION: 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

    IT WAS REPORTED THAT THE SURGEON INSERTED A CQ2015A THREE PIECE COLLAMER LENS AND A HAPTIC TORE UPON INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURED AFTER ANOTHER LENS WAS IMPLANTED.

    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. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STAARVISC II| CARTRIDGE MODEL CQ CARTRIDGE-FP| INJECTOR MODEL MSI-PM