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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 06/11/2001
Event Type  Injury  
Event Description

Lasik surgery. No specific adverse event date. See info contained herein. Ghosting. After lasik surgery, eyesight was about 20/20 and 20/30, ghosting double in one eye and ghosting triple in the other. Ghosting was not disclosed as a potential side effect, and i never even heard that term until i read a article published after my surgery. -surgery was in 2001, i believe. Regression. Within about six months, my eyesight had regressed to about 20-80 and 20-200, and has continued to regress. Regression was never disclosed as a potential problem/side effect. Dry eye syndrome. An optometrist inserted punctal plugs and lutien supplements were taken. While the goal was to leave enough cornea for an enhancement, the post-lasik corneas were judged to be too steep for an enhancement. Furthermore, a second surgery probably would result in regression, leaving even thinner, dryer corneas. Treatment for dry eyes did not increase corneal thickness enough for an enhancement. Today, i use contact lenses to correct myopia and astigmatism; they are multi-focal lenses. I cannot use the contact lenses that are hard-centered and soft-rimmed, since they inflamed the lasik-rim on my cornea. Currently, eyesight is not completely corrected, and there are halos/starbursts and ghosting with contact lenses. The lasik surgeon was one of the most-experienced and most-recommended lasik surgeons. He was one of the original 13 fda researchers for lasik. Dates of use: 2001. Diagnosis: myopia; astigmatism. Lasik surgery, date was 2001, i will give permission to obtain post-surgery info from ophthalmologist and optometrists if it helps folks in the future.

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Type of DeviceLASIK
MDR Report Key1517747
Report NumberMW5013184
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/25/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No

Date Received: 10/25/2009 Patient Sequence Number: 1