BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1945288 · Received December 21, 2010

    Report

    Report Number
    2023826-2010-01286
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 8, 2010
    Manufacturer
    STAAR JAPAN INC.
    Product Code
    MSS
    PMA / PMN Number
    K090161
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT 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 BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. EVALUATION: METHOD: OTHER, LENS WORK ORDER SEARCH. RESULTS: OTHER, A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOND WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL 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 INDICATED A 06.0 DIOPTER AQ2010V SILICONE THREE PIECE LENS WAS DAMAGED IN THE EPIPHANY INJECTOR SYSTEM, THERE WAS NO PT CONTACT. THE REPORTER STATED, THE LENS DAMAGE WAS CAUSED BY THE INJECTOR SYSTEM.

    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)