BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1021098 · Received March 27, 2008

    Report

    Report Number
    2023826-2008-00435
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 6, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVAL. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND THE LENS OPTIC TORN AND ONE HAPTIC TORN OFF. THERE WAS EVIDENCE OF REDDISH RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVAL. EVAL: A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS: AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CANNOT BE DEFINITIVELY AND EXCLUSIVELY CORRELATED TO A SPECIFIC ROOT CAUSE. POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYS ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. TO ADDRESS DELIVERY SYSTEM ISSUES, ALL STAGES IN THE MFG 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

    THE REPORTER STATED, THE SURGEON INSERTED AND REMOVED A 14.5 DIOPTER AQ2010V SILICONE THREE PIECE LENS DUE TO THE FRONT HAPTIC TEARING OFF DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER SAME TYPE LENS WAS IMPLANTED. SUTURES WERE REQUIRED TO CLOSE THE INCISION. THE REPORTER STATED, IT WAS THE SURGEON'S OPINION THAT THE LIKELY CAUSE OF THE EVENT WAS DUE TO THE AQ CARTRIDGE-FP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. AQ CARTRIDGE-FP 1234444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR MODEL: MSI-TM LOT NUMBER: UNK| LENS MODEL AQ2010V