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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Date 08/15/2008
Event Type  Injury  
Event Description

Ophthalmologist performed lasik surgery too soon after stopping wearing rgp contact lenses. He said my eyes were stable only 3 weeks after giving up these rgp lenses. They were not. As a result, my eyes continued to change drastically for several months after the procedure. I went from being myopic, about 8. 00 diopters to hyperopic. He also left me with very significant striae in my cornea, especially the left one. He tried to "iron out the wrinkle" the next morning. The visual lack of acuity continued for a long time and he would not tell me what was wrong with my vision. I finally was compelled to go to another ophthalmologist in the area, who said a special procedure had to be done immediately to try to get the striae out. I then had to go under this procedure which was not covered by insurance. This helped to a large extent. I could not, however, get a refraction for glasses or contacts for about 4 yrs that would correct my vision. I now have to wear rgp lenses once again. Eyeglasses cannot be prescribed as they will not work. Therefore, i can't correct my vision - for example when my eyes are inflamed or irritated- unless i'm wearing them.

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key1187773
Report NumberMW5008535
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/03/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2008
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

Date Received: 10/03/2008 Patient Sequence Number: 1