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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NONE NONE

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Event Date 01/18/2008
Event Type  Injury  
Event Description

Refractive surgery performed for mild myopia by (b)(6) eye institute, (b)(6). Since this procedure, i have experienced severe dry eyes, requiring daily drops and night halos from headlights/street lights that limit evening driving. Sunlight glare is also extremely painful, and i must wear dark sunglasses now. The correction from the surgery reversed almost immediately,- started within 1 week- and according to my optometrist, 2 years later, i have regressed 25% and 40% from (b)(6) back to my original prescription. I advised (b)(6) from the first exam that i train horses and am in a dusty arena daily, and i drive at night with a 40 ft horse trailer to shows in (b)(6). They said their procedure rarely caused problems. Less than 1% they said, and i was an excellent candidate with little correction. Everything would be fine, and i wouldn't need contacts anymore. It is difficult to train horses with the dust in the arena, and wear contacts or glasses. At my last appointment, in (b)(6) 2010, their response was to give me a script for restasis at a cost (b)(6), which i cannot afford, and said only another procedure would correct the halo problems. They said halos are from uncorrected astigmatism. I refused to have my eyes re-corrected again with lasik in (b)(6), and asked for a partial refund. They agreed, but then never followed through, and have ignored all of my written communications with them.

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Brand NameNONE
Type of DeviceNONE
Manufacturer (Section D)
MDR Report Key1817589
Report NumberMW5017235
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/24/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2010
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: 08/24/2010 Patient Sequence Number: 1