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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK/PRK EYE CORRECTION SURGERY DEVICES

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LASIK/PRK EYE CORRECTION SURGERY DEVICES Back to Search Results
Event Date 02/10/2006
Event Type  Injury  
Event Description

Lasik, prk eye surgery left eye prk, right eye lasik. Extreme difference from l to r eye. Left eye also still has bad astigmatism, had to get prescription reading glasses for one eye to slow down headaches. I paid the extra per eye, for lifetime touch up. After waiting 1 yr, i went back to see if they could balance out the eye better and was told no. Unless they get worse than 20/40 they would not do it. That was not told to me at the time of surgery. Why pay the extra money then? i am now very light sensitive. As my md told me, photo-phobic. The need for sunglasses is all the time and i have even had a few episodes that were so severe that i had to pull over when driving. It is interfering with my work. Floaters or what i would term as dirt floating around in the eyes, which is really loose blood vessels. I was told that these would go away after a few weeks as they started shortly after the surgery. It's been a year and a half and there's still a lot of them.

 
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Brand NameLASIK/PRK
Type of DeviceEYE CORRECTION SURGERY DEVICES
Device Event Key1007614
MDR Report Key1038117
Event Key996473
Report NumberMW5006698
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/04/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 05/04/2008 Patient Sequence Number: 1
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