BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1211330 · Received October 22, 2008

    Report

    Report Number
    2023826-2008-01328
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 25, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER?: NO (OTHER): THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED, AND VISUAL INSPECTION FOUND ONE HAPTIC TORN AND BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE CARTRIDGE WAS NOT RETURNED FOR EVALUATION. EVALUATION: CONCLUSION: 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, 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

    THE REPORTER STATED THAT THE SURGEON ATTEMPTED TO INSERT A 21.0 DIOPTER AQ2003V SILICONE THREE PIECE LENS, BUT THE LENS WAS DAMAGED BY THE INJECTOR. THERE WAS NO PT CONTACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MSI-TM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP| LENS: MODEL AQ2003V