BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THEE PIECE FOLDABLE INTRAOCULAR

    MDR report key: 1222073 · Received November 6, 2008

    Report

    Report Number
    2023826-2008-01351
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 10, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSIONS: (OTHER) - AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 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 OFF DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS, AND SUTURES CLOSED THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THEE PIECE FOLDABLE INTRAOCULAR INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CARTRIDGE: MODEL AQ CARTRIDE-FP| INJECTOR: MODEL MSI-TM