BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1923781 · Received December 2, 2010

    Report

    Report Number
    2023826-2010-01226
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    September 15, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL CONCLUSIONS - AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED IN JUNE 2005 (WHICH WAS SUBSEQUENTLY CLOSED). THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MFG OF THE INJECTORS AND CARTRIDGES. PROCESSES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. THE CAPA ALSO ADDRESSED 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. BASED ON THE COMPLAINT HISTORY, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND HANDLING ERRORS BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED AS THE SURGEON THAT THE AQ2010V THREE PIECE SILICONE LENS SPLIT, AS IT WAS COMING OUT OF THE INJECTOR AND INSERTED INTO THE EYE. THE LENS WAS 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 68 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT# UNK| INJECTOR: MODEL MSI-TM, LOT# UNK