BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1920711 · Received October 28, 2010

    Report

    Report Number
    2023826-2010-01083
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN INTO TWO PIECES. A PIECE OF THE LENS OPTIC AND ONE HAPTIC WERE TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS AND THE HAPTIC TORE. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES.

    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 CARTRIDGE: MODEL CQ CARTRIDGE-FP, LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK