BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1080963 · Received July 23, 2008

    Report

    Report Number
    2023826-2008-00970
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 30, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES, RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS A HAPTIC IS TORN OFF INTO THE OPTIC OF THE LENS. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL. CONCLUSIONS: AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. TO ADDRESS DELIVERY SYSTEM ISSUES, ALL STAGES IN THE MANUFACTURING OF THE INJECTORS AND CARTRIDGES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. TO ADDRESS HANDLING ERRORS, ALL 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 HAD INSERTED A THREE PIECE SILICONE LENS MODEL AQ2003V IN THE PATIENT'S EYE AND HE NOTICED THE HAPTIC WAS TORN OFF. THE SURGEON ENLARGED THE INCISION TO REMOVE THE LENS AND PUT IN ANOTHER SAME TYPE LENS IN THE EYE AND USED A SUTURE TO CLOSE THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT NUMBER: 1235353| INJECTOR MODEL: MSI-PM LOT NUMBER: UNK| CARTRIDGE MODEL: AQ CARTRIDGE-FP