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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOMVUE WAVEFRONT LASIK NONE

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CUSTOMVUE WAVEFRONT LASIK NONE Back to Search Results
Event Date 07/16/2005
Event Type  Injury  
Event Description

I had lasik eye surgery and have suffered numerous side effects in my vision. Including a loss of peripheral vision in both eyes, floaters, regions of depressed sensitivity in day light vision. Night vision has degraded significantly and my vision has a yellowish tint. In addition, i require daily eye drops for dryness and get flashing migraine headaches on occasions. I have extreme difficulty reading, and can not do technical work anymore. I deal with eye pain and eye strain daily. Additionally, my eyes are very sensitive to sunlight. Now i just go to college and live off the proceeds of my house. I am also registered with the learning disabilities center as visually impaired. Yet, my eye dr says my vision is 20/40 and i am fine. I still need eye drops for dryness 2. 5 years later. Additionally, i feel that my eye dr who did the lasik procedure is not being truthful with me and i have to pay for this checkups every six months for the rest of my life. I am getting ready to apply for disability.

 
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Brand NameCUSTOMVUE WAVEFRONT LASIK
Type of DeviceNONE
MDR Report Key1074478
Report NumberMW5007611
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/10/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2008
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
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/10/2008 Patient Sequence Number: 1
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