BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1912254 · Received November 23, 2010

    Report

    Report Number
    2023826-2010-01188
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 25, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, WERE ADDRESSED IN A CAPA OPENED IN (B)(4) 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT AN (B)(4) SILICONE THREE PIECE LENS AND THE HAPTIC TORE. THERE WAS NO PT CONTACT OR INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED.

    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. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR CARTRIDGE: MODEL AND LOT # UNK| INJECTOR: MODEL AND LOT # UNK