BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2233482 · Received September 2, 2011

    Report

    Report Number
    2023826-2011-00761
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS TORN INTO FOUR PIECES. THERE WAS EVIDENCE OF BROWNISH RESIDUE ON THE LENS SURFACE. CONCLUSIONS: 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. 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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) WITH TORIC OPTIC. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS (IOL), TORN, SPLIT, CRACKED, DEVICE EVALUATED BY MANUFACTURER, LENS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - ANOTHER IOL WAS IMPLANTED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED AN AA4203TL TORIC SILICONE SINGLE PIECE LENS AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AQ CARTRIDGE-FP - LOT # 1260831| INJECTOR MODEL AND LOT NUMBER UNK