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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Device Problem Insufficient Information (3190)
Patient Problems Glaucoma (1875); Keratitis (1944); Blurred Vision (2137)
Event Date 12/09/2010
Event Type  Injury  
Event Description

I had lasik on both eyes in (b)(6) 2010. Since then, i have spent (b)(6) and spent countless hours at the doctor. My left eye is almost as good as it was prior to lasik. My right eye on the other hand is no where near where it was prior to lasik. My vision is blurry. I can not read 20/20 on the eye chart. I am lucky that i can still see out of my right eye. I reported to my lasik doctor that i was having problems and he dismissed me. This has devastated myself and my family. I was told prior to the surgery that i would be able to return to normal after about one day post op. That is so not true. I am currently on over the counter eye drops, restasis, pred forte and combigan. My current iop is in the 20's as a result of the steroids and the glaucoma med. I have had steroid induced glaucoma as well as three incidences of dlk -sands of the sahara-. When i told dr (b)(6) of (b)(6) that i was having trouble seeing he told me i must have health issues and to see a doctor. After seeing every kind of doctor under the sun; chiropractor, family doctor and a psychiatrist, i got a second opinion from a different ophthalmologist who diagnosed me with dlk and started me on the steroid and returned me back to dr (b)(6). After many more months of poor vision, i consulted with a third ophthalmology office who concluded that after not having my pressure checked and being on steroids non stop, i was a steroid responder. This doctor told me to discontinue the steroids and return to dr (b)(6) for f/u. Ten months op and i am still seeing dr (b)(6) with no improvement in my vision. He never performed an enhancement but he did lift the flap and irrigate it at one point.

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2285523
MDR Text Key2350928
Report NumberMW5022539
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 10/04/2011 Patient Sequence Number: 1