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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRK REFRACTIVE SURGERY NONE

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PRK REFRACTIVE SURGERY NONE Back to Search Results
Event Date 07/02/2007
Event Type  Injury  
Event Description

I had refractive surgery - prk - not lasik - last summer and i have had severe, chronic dry eyes ever since. I was not informed of this side effect or screened for it. The post-operative care that i have received for this side effect has been inadequate and i am left to fend for myself. The cost has been outrageous. I hope that the fda takes all refractive surgeries into consideration when reviewing chronic dryness issues; chronic dry eye is not just a problem with lasik. This condition has been life altering and disabling.

 
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Brand NamePRK REFRACTIVE SURGERY
Type of DeviceNONE
MDR Report Key1047143
Report NumberMW5006910
Device Sequence Number1
Product CodeHQF
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/16/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 05/16/2008 Patient Sequence Number: 1
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