BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 1810585 · Received August 2, 2010

    Report

    Report Number
    2936921-2010-00004
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    August 28, 2008
    Report Date
    July 9, 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 07/26/2010 NIDEK INC WAS NOTIFIED BY A LETTER FROM FDA INDICATING A PT INJURY HAD OCCURRED IN 2008. NIDEK INC. DID NOT RECEIVE ANY PRIOR NOTIFICATION OF PT INJURY. LASIK PROCEDURE FOR PERFORMED (B)(6) 2008. CENTRAL ISLANDS ARE STEEP SPOTS ON THE CORNEA AFTER LASIK. REPORTED CAUSES OF CENTRAL ISLANDS INCLUDE SHIELDING OF THE CORNEAL BED BY PULVERIZED TISSUE PLUME, COLLECTION OF FLUID IN THE CENTER OF THE CORNEA AS THE ABLATION IS PERFORMED, NON-HOMOGENEITY OF THE LASER BEAM, REGIONAL DIFFERENCES IN CORNEAL HYDRATION, AND LARGE ABLATION DIAMETERS. SYMPTOMS INCLUDE GHOST IMAGING, HALOS, STARBURSTS, NIGHT-DRIVING DISABILITY, REDUCED BEST-CORRECTED VISUAL ACUITY, LOSS OF CONTRAST SENSITIVITY, AND DOUBLE VISION. A CENTRAL ISLAND MAY BE REFERRED TO AS AN IRREGULAR ASTIGMATISM. 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) 2008 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 07/26/2010, 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) 2008. THE PT IS COMPLAINING OF CENTRAL ISLAND/VISUAL DISTURBANCES AFTER LASIK. 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