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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NADIK NONE

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NADIK NONE Back to Search Results
Event Date 02/14/2008
Event Type  Injury  
Event Description

In 2008, i underwent lasik on both eyes in the offices or dr. The next day my vision was very blurry and i went back to dr and was told that my flaps were too thin and that i would need an enhancement surgery, but this may not correct the problem. When i asked why this happened, i was told that, "it is just medicine" by dr. He also asked the equipment mfr why all the machines told us i was the "perfect candidate" for lasik and then this happened. They also had no response. I believe the maker of the equipment is nadik. So now i have gotten 3 second opinions and all agree that it may be fixable with add'l ptk surgery, a yr of treatments.

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Brand NameNADIK
Type of DeviceNONE
MDR Report Key1077192
Report NumberMW5007656
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 07/15/2008 Patient Sequence Number: 1