BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3013273 · Received March 20, 2013

    Report

    Report Number
    2023826-2013-00219
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE OPTIC WAS TORN OFF AND MISSING AND 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, 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 TWO AQ2010V SILICONE THREE PIECE LENSES TORE AS THE SURGEON INSERTED THEM INTO THE EYE. THIS LENS WAS REMOVED WITHOUT ENLARGING THE INCISION AND A SUTURE CLOLSED THE WOUND AFTER THE THIRD LENS WAS IMPLANTED. SEE MFR REPORT #2023826-2013-00218 FOR THE OTHER INCIDENT INVOLVING THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116329 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 AQ CARTRIDGE MODEL, LOT NUMBER UNKNOWN| MSI-TM INJECTOR MODEL, LOT NUMBER UNKNOWN