BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4084725 · Received August 28, 2014

    Report

    Report Number
    3002807715-2014-00010
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    January 1, 2012
    Report Date
    August 22, 2012
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    PMA / PMN Number
    K893987S
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED TO NIDAK FOR EVALUATION. HOWEVER, A NIDEK FIELD SERVICE ENGINEER (FSE) HAD CONDUCTED AN ON-SITE EVALUATION. THE TREATMENT OUTPUT ENERGIES WERE CHECKED AND WERE WITHIN SPECIFICATIONS. THE FSE CHECKED THE FOCUS SHIFT AND WAS WITHIN SPECIFICATIONS. NO FAILURE WAS FOUND. NIDEK CONTACTED THE CUSTOMER AND CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT ASSOCIATED TO THE EVENT. IF ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NIDEK INC. CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    NIDEK INC RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2012. WHILE USING THE YC-1800, (B)(4), DOCTOR FELT THAT THERE WAS LOT OF PITTING IN LENS. DOCTOR ALSO MENTIONED THAT THEY TIRED TO ADJUST THE FOCUS SHIFT BUT STILL HAD PITTING IN LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523675 YC-1800 ND: YAG LASER LZS NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK