BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1191567 · Received October 1, 2008

    Report

    Report Number
    2023826-2008-01244
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 11, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE OPTIC WAS TORN AND BOTH HAPTICS WERE TORN OFF AND ONE HAPTIC WAS MISSING. THERE WAS A CLEAR A CLEAR SURGICAL RESIDUE ON THE LENS. CONCLUSION: AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CAN NOT BE DEFINITIVELY AND EXCLUSIVELY CORRELATED TO A SPECIFIC ROOT CAUSE. 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 INSERTED AN AQ2010V THREE PIECE SILICONE LENS AND THE TRAILING HAPTIC TORE UPON INSERTION. THE LENS WAS CUT INTO PIECES AND REMOVED WITHOUT ANY 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 CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR LOT NUMBER UNK| LOT NUMBER UNK| INJECTOR MODEL MSI-PM| CARTRIDGE MODEL AQ CARTRIDGE-FP