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U.S. Department of Health and Human Services

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

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NIDEK EC-5000 EXCIMER LASER SYSTEM Back to Search Results
Event Date 06/15/2004
Event Type  Injury  
Event Description

In (b) (6) 2004, i underwent the lasik procedure. In 2008, i discovered that i had developed the lasik-related complication known as ectasia -aka, iatrogenic keratoconus or secondary keratoconus-. This has had a significant negative impact on my vision, well-being, and quality of life.

 
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Brand NameNIDEK EC-5000 EXCIMER LASER SYSTEM
Type of DeviceNIDEK EC-5000 EXCIMER LASER SYSTEM
MDR Report Key1621653
Report NumberMW5014972
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 02/25/2010 Patient Sequence Number: 1
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