BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1220456 · Received November 4, 2008

    Report

    Report Number
    2023826-2008-01359
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 7, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN, WITH A PIECE TORN OFF AND MISSING. ONE HAPTIC WAS TORN AND THE OTHER HAPTIC WAS BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. 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 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 THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS, BUT THE LENS WAS REMOVED DUE TO A BENT HAPTIC. THE INCISION WAS ENLARGED TO REMOVE THE LENS, AND ANOTHER LENS WAS IMPLANTED. A SUTURE WAS REQUIRED TO CLOSE THE INCISION.

    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 COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE: MODEL CQ CARTRIDGE-FP-LOT NUMBER UNK| INJECTOR: MODEL MSI-PM