BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 1836196 · Received July 30, 2010

    Report

    Report Number
    2936921-2010-00003
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    March 26, 2009
    Report Date
    June 26, 2010
    Manufacturer
    NIDEK CO. LTD
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/20/10, NIDEK INC WAS NOTIFIED BY A LETTER FROM FDA INDICATING A PT INJURY HAD OCCURRED IN 2009. NIDEK INC DID NOT RECEIVE ANY PRIOR NOTIFICATION OF PT INJURY. LASIK PROCEDURE WAS PERFORMED ON (B)(6)2009. VISION CORRECTED WITH SOFT CONTACT LENSES PRIOR TO LASIK. SIXTEEN (16) MONTHS POST LASIK, SEVERE DRY EYE SYNDROME AND NIGHT VISION DISTURBANCES INCLUDING GLARE, HALOES, STARBURSTS AND LOSS OF CONTRAST ABILITY NOTED. NIGHT VISION DISTURBANCES NOTED IMMEDIATELY AFTER LASIK. DRY EYES STARTED THREE (3) MONTHS AFTER LASIK. VISION PERMANENTLY CHANGED. DRY EYE IS THE MOST COMMON COMPLICATION OF LASIK. CORNEAL NERVES THAT ARE RESPONSIBLE FOR TEAR PRODUCTION ARE SEVERED WHEN THE FLAP IS CUT. NIGHT VISION DISTURBANCES LASIK PTS HAVE MORE DIFFICULTY SEEING DETAIL IN DIM LIGHT (LOSS OF CONTRAST SENSITIVITY) AND EXPERIENCE AN INCREASE IN VISUAL DISTORTION AT NIGHT (MULTIPLE IMAGES, HALOS, AND STARBURSTS). WE PROVIDED NECESSARY INFO AND TRAINING TO SURGICAL DOCTORS WHO USE EC-5000 TO PREVENT ADVERSE EVENTS. THE INFO INCLUDES CONTRAINDICATION, PRECAUTION, AND PT SELECTION. WE HAVE NO REPORTED DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO REPORTED ADVERSE EVENT FROM (B)(6)2009 TO PRESENT DATE. THIS OUTCOME IS CONSIDERED A SIDE EFFECT OF LASIK SURGERY BY EC-5000 EXCIMER LASER SYSTEM. BASED ON THE INFO PRESENTED, NIDEK INC IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INJURY. IF FURTHER INFO IS RECEIVED, WE WILL SUBMIT A FOLLOW UP.

    Description of Event or Problem · 1

    ON (B)(6)2010, NIDEK INC RECEIVED A LETTER STATING MAUDE EVENT REPORT, (B)(4) RELATED TO EC-5000 EXCIMER LASER SYSTEM. THIS LETTER STATED A PT HAD LASIK ON (B)(6)2009. THE PT IS COMPLAINING OF DRY EYE SYNDROME AND NIGHT VISION DISTURBANCES AFTER LASIK. SYMPTOMS OF DRY EYE SYNDROME DID NOT BECOME NOTICEABLE UNTIL 3 MONTHS. NIDEK INC PREPARED THE CUSTOMER COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO. LTD EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention