BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 1686295 · Received May 10, 2010

    Report

    Report Number
    2936921-2010-00002
    Event Type
    Injury
    Date Received
    May 10, 2010
    Date of Event
    May 20, 2002
    Report Date
    April 6, 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 MAY 3, 2010, NIDEK INC WAS NOTIFIED BY A LETTER FROM THE FDA INDICATING A PATIENT INJURY HAD OCCURRED IN 2002. NIDEK INC DID NOT RECEIVE ANY PRIOR NOTIFICATION OF PATIENT INJURY. GENERALLY, IRREGULAR ASTIGMATISM OCCURS DURING REFRACTIVE SURGERY WHEN THE LASER DOES NOT LEAVE A SMOOTH SURFACE. THE MORE UNEVEN THE SURFACE CREATED BY THE LASER, THE BIGGER THE VISUAL DISTORTION. SOME CAUSES OF IRREGULAR ASTIGMATISM ARE: DECENTERED TREATMENTS- AREA TREATED WAS NOT CENTERED ON THE VISUAL AXIS. SMALL OPTICAL ZONES- AREA TREATED WAS SMALLER THAN THE SPHERE AND CYLINDER ON THE CORNEA I.E. SPHERE AND CYLINDER EXPANDED TO 7MM AND THE OPTICAL ZONE TREATED WAS ONLY 5MM LEAVING A 2MM RING OF UNTREATED AREA. CENTRAL ISLANDS- 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. OBLATE CORNEAS- AN OBLATE CORNEA INDUCES NIGHT MYOPIA AND SPHERICAL ABERRATION. DESTABILIZED CORNEAS- CORNEAS THAT ARE NO LONGER STABLE I.E. CONTACT LENS WARPAGE, DECOMPRESSION, ETC. NIDEK INC PROVIDED NECESSARY INFORMATION AND TRAINING TO SURGEONS WHO USE THE EC-5000 EXCIMER LASER SYSTEM TO PREVENT ADVERSE EVENTS. BASED ON THE INFORMATION PRESENTED, NIDEK INC IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INJURY. IF FURTHER INFORMATION IS RECEIVED, WE WILL SUBMIT A FOLLOW UP.

    Description of Event or Problem · 1

    ON MAY 3, 2010, NIDEK INC RECEIVED A LETTER STATING MAUDE EVENT REPORT RELATED TO THE EC-5000 EXCIMER LASER SYSTEM. THIS LETTER STATED AN UNKNOWN PATIENT HAD BILATERAL HYPEROPIC LASIK ON (B) (6) 2002, BY THE NIDEK EXCIMER LASTER BEFORE IT WAS APPROVED FDA APPROVED FOR HYPEROPIC TREATMENTS. THE PATIENT NOW SUFFERS FROM IRREGULAR ASTIGMATISM AND BLURRY VISION. THIS MAUDE REPORT WAS CREATED BY A PHYSICIAN THAT HAS SEEN THE UNKNOWN PATIENT. ACCORDING TO THIS INFORMATION, THE PATIENT SOUGHT MEDICAL INTERVENTION. 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