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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 09/25/2006
Event Type  Injury  
Event Description

I had lasik to correct my vision and now i have extremely dry eyes. I am using restasis - prescription, prophylactic antibiotics, artificial tears, genteal gel, muro 128 ointment. I do eyelid scrubs and eyelid warm compress twice per day. I have to wear goggles to ride my bike or do any outside activity. I can stand heating or air-conditioning if it's too near me. During my screening, i discussed the fact that my eyes were slightly dry. I asked if the dryness would increase after lasik. The doctor told me that they tested my tears and i wouldn't have any problem. The literature provided to me said that permanent dry eye was rare after lasik. I trusted my doctor and the literature provided. I am so miserable now. I have never achieved a point in 2 years where i felt that my eyes were stable and comfortable. I may have to undergo another surgery at some point to dry to correct erosions of my cornea. I have a condition known as abmd -anterior basement membrane dystrophy- which lasix center did not screen for. The dry eyes cause erosions and the abmd makes it very difficult for my eyes to heal. I feel that i wasn't given the correct info before making my decision to have lasik, and i will be paying for it for the rest of my life -monetarily and in the pain i constantly am suffering-. Lasik center definitely should be required to provide candidates with all of the risk factors prior to surgery.

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Type of DeviceLASIK
MDR Report Key1157868
Report NumberMW5008272
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/10/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Date Received: 09/10/2008 Patient Sequence Number: 1