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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIDEK CO., LTD. MK-2000, KERATOME AND/OR EC-5000 EXCIMER LASER MK-2000 AND/OR EC-5000

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NIDEK CO., LTD. MK-2000, KERATOME AND/OR EC-5000 EXCIMER LASER MK-2000 AND/OR EC-5000 Back to Search Results
Model Number MK-2000
Event Type  Injury  
Event Description

Patient has allegedly claimed on a public broadcast news report that she was injured during a lasik surgery procedure, which resulted in her requiring sutures on her right cornea and know has a cataract forming.

Manufacturer Narrative

Based on the information presented in the news broadcast, nidek inc is unable to determine the root cause of this injury. Nidek has trained this facility on the proper use of both the ec-5000 and the mk-2000. Nidek has even re-trained this facility on the proper use of the nidek devices. Nidek has provided this facility with on-going guidance on maintaining their devices. No further information of the patient injury is available and has not been presented to nidek. There is no confirmation of this claim and no confirmation of which devices caused this injury. If further information is received, nidek will submit a follow up report. Additional model #: ec-5000.

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Type of DeviceMK-2000 AND/OR EC-5000
Manufacturer (Section D)
Manufacturer (Section G)
34-14 maehama, hiroishi-cho
gamagori, aichi 443- 0038
JAPAN 443-0038
Manufacturer Contact
neo yamaguchi
47651 westinghouse dr.
fremont , CA 94539
MDR Report Key1294955
Report Number2936921-2009-00001
Device Sequence Number1
Product CodeHNO
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/26/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/26/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device MODEL NumberMK-2000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2009
Distributor Facility Aware Date01/15/2009
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer01/26/2009
Date Manufacturer Received01/26/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Date Received: 01/26/2009 Patient Sequence Number: 1