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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIDEK CO. LTD NIDEK MK-2000, KERATOME & EC-5000 KERATOME, AC POWERED & EXCIMER LASER

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NIDEK CO. LTD NIDEK MK-2000, KERATOME & EC-5000 KERATOME, AC POWERED & EXCIMER LASER Back to Search Results
Model Number MK-2000 & EC-5000
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury  
Event Description

The information provided in the copy of the legal complaint alleges that the patient had undergone lasik surgery in 2008 (actual date unknown), and one day post operatively required a "re-float" of both flaps, where immediately following she allegedly starting having problems (type of problems were not disclosed). The legal complaint states that according to a licensed medical professional, the patient "has severe dry eyes, her vision is significantly impaired. She has dramatic corneal folds in her left eye. Her best corrected vision is 20/70 - right eye and 20/60-left eye. She will likely have permanent vision loss in both eyes. ".

 
Manufacturer Narrative

In 2009, nidek inc was notified by service that the alleged patient injury had occurred in 2008 (actual date unknown). This notification came via the injured patient's attorney. Nidek did not receive any prior notification of any patient injury. Once we received the notification of patient injury, we began an investigation process, however, the facility where the alleged patient injury occurred is now closed. Regarding results and conclusion - these codes were selected due to the fact that the device was never sent in to the manufacturer for inspection. 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 report.

 
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Brand NameNIDEK MK-2000, KERATOME & EC-5000
Type of DeviceKERATOME, AC POWERED & EXCIMER LASER
Manufacturer (Section D)
NIDEK CO. LTD
34-14 maehama
hioishi-cho gamagori, aichi 443- 0038
JAPAN 443-0038
Manufacturer (Section G)
NIDEK CO. LTD
34-14 maehama
hiroishi-cho gamagori, aichi 443- 0038
JAPAN 443-0038
Manufacturer Contact
neo yamaguchi
47651 westinghouse dr.
fremont , CA 94539
5103537708
MDR Report Key1349755
Report Number2936921-2009-00005
Device Sequence Number1
Product CodeHNO
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 03/18/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMK-2000 & EC-5000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2009
Distributor Facility Aware Date02/27/2009
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer03/18/2009
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

Patient TREATMENT DATA
Date Received: 03/18/2009 Patient Sequence Number: 1
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