BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1912190 · Received November 17, 2010

    Report

    Report Number
    2023826-2010-01151
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS SPLIT IN HALF AND A PIECE OF THE OPTIC AND A HAPTIC WERE TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED IN 06/2005 (WHICH WAS SUBSEQUENTLY CLOSED). THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MANUFACTURING 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 AND THE EVALUATION OF THE RETURNED PRODUCT, 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

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ2015A THREE PIECE SILICONE LENS AND THE LENS TORE UPON INSERTION. THE LENS WAS CUT OUT OF THE EYE WITHOUT ENLARGING THE INCISION AND THERE WAS 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 COMPANY AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT NUMBER UNK| INJECTOR: MODEL MSI-TM, LOT NUMBER UNKNOWN