BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 2002138 · Received February 2, 2011

    Report

    Report Number
    2023826-2011-00084
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 5, 2011
    Manufacturer
    STAAR JAPAN INC.
    Product Code
    MSS
    PMA / PMN Number
    K090161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND A PIECE OF THE LENS OPTIC AND ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED A 22.0 DIOPTER AQ2010V SILICONE THREE PIECE LENS TORE UPON INSERTION AND WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE INJECTOR SYSTEM MAY HAVE CAUSED THE LENS DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR JAPAN INC. EPIPHANY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS: MODEL AQ2010V - (B)(4)