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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BILATERAL PRK SURGERY NONE

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BILATERAL PRK SURGERY NONE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Discomfort (2330)
Event Date 02/12/2010
Event Type  Injury  
Event Description

I had bilateral prk on (b)(6) 2010. I got laser surgery, in hopes that i wouldn't have to wear eye glasses, since i have worn corrective lenses since i was (b)(6). I didn't have trouble with night vision prior to the surgery and now since the surgery i do. Also, now i have dry eyes that require restasis twice a day and other lubricating eye drops as needed throughout the day. I occasionally have eye discomfort, also. I need to wear eye glasses, for driving. I have had three different pairs made since my surgery, due to vision changes. I was not aware these side effects would occur.

 
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Brand NameBILATERAL PRK SURGERY
Type of DeviceNONE
MDR Report Key2626288
MDR Text Key2727010
Report NumberMW5025901
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/18/2012 Patient Sequence Number: 1
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