BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031381 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00555
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MFG 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

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A THREE PIECE SILICONE LENS MODEL AQ2010V AND A HAPTIC TORE OFF. THE SURGEON REMOVED THE LENS WITHOUT ENLARGING THE INCISION ANOTHER SAME TYPE MODEL WAS INSERTED. THEY USED A CQCARTRIDGE WITH THIS LENS WHICH IS NOT RECOMMENDED. NO PT INJURY.

    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 AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL CQ CARTRIDGE-FP| INJECTOR MODEL MSI-TM LOT # UNK