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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIDEK NIDEK EC-5000 EXCIMER LASER

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NIDEK NIDEK EC-5000 EXCIMER LASER Back to Search Results
Model Number EC-5000
Event Type  No Answer Provided  
Event Description

Dr. (b)(6) performed lasik procedure on me on (b)(6) 2000. Eyes after six-years went bad because of thin corneas due to surgery. Would like to communicate to avoid this with other pts in future. Lasik procedure done by dr. (b)(6) m. D. With nidek ec-5000 excimer laser. Resulted in loss of correctional sight. Diagnosed with lasik induced thinning of corneas keratoconus.

 
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Brand NameNIDEK EC-5000
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
NIDEK
MDR Report Key1951117
Report NumberMW5018845
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberEC-5000
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 12/30/2010 Patient Sequence Number: 1
Treatment
PRESCRIBED GAS PERMEABLE CONTACT LENSES THAT ARE
VERY UNCOMFORTABLE TO WEAR DUE TO SURGERY.
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