BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3953838 · Received July 23, 2014

    Report

    Report Number
    2023826-2014-00540
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 27, 2014
    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

    METHOD: WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER SEARCH. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THE LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY ROOT CAUSE TO THE LENS TEARING IS USER ERROR OR CARTRIDGE LUBRICITY. THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION CODES: METHOD CODE: (PROCESS EVALUATION): MEDICAL REVIEW. RESULTS CODE: (EVALUATION RESULT): PER MEDICAL REVIEW - THE TEAR OBSERVED DURING SURGERY MAY HAVE OCCURRED AT ANY STAGE FROM MANUFACTURE, THROUGH LENS LOADING TO SURGICAL MANIPULATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED A TEAR ACROSS THE LENS AND HALF OF THE HAPTIC AND A PIECE OF THE OPTIC WAS TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. 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 CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AA4203TL SILICONE SINGLE PIECE LENS TORE JUST AS THE SURGEON PLACED IT IN THE EYE. THE LENS WAS REMOVED IMMEDIATELY AND THE REPLACEMENT LENS WAS IMPLANTED WITHOUT PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431270 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR MSI-TR INJECTOR MODEL, LOT NUMBER UNKNOWN