BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK YAG LASER YC-1300

    MDR report key: 3415461 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00007
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    December 19, 2011
    Report Date
    October 10, 2013
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS SOLD TO ANOTHER FACILITY 12 YRS AGO W/O NIDEK INC. KNOWLEDGE. THERE WAS NO SERVICING OR CALIBRATION AFTER SECOND SALE. DEVICE INSPECTION WAS RECOMMENDED BY NIDEK INC., BUT THE USER REFUSED IT BECAUSE THEY WILL NOT USE THE UNIT ANY LONGER. NIDEK CO., LTD. DETERMINE THAT THE INCIDENT OCCURRED DUE TO HANDLING PROBLEM AS NIDEK INC. REPORTS.

    Description of Event or Problem · 1

    NIDEK WAS ACCIDENTALLY NOTIFIED OF MDR REPORTABLE ADVERSE EVENT. YAG CAPSULOTOMY PERFORMED ON (B)(6) 2011 ON YC-1300 SN (B)(4) BY DR (B)(6) SHATTERED IOL AFTER SECOND BURST. SURGICAL INTERVENTION WAS OCCURED LATER THAT DAY ((B)(6) 2011): DR (B)(6) IRRIGATED SHATTERED LENS, NO PIECES WENT INTO THE VITREOUS, NO INJURY TO BAG, PT DOING FINE AND IS NOW APHAKIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522628 NIDEK YAG LASER YC-1300 NONE LZS NIDEK CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention