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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 04/01/2002
Event Type  Injury  
Event Description

I had lasik performed on both eyes by a dr at the facility in 2002. I don't remember the exact date. Since then, i have had an uncomfortably dry eye on the left side, and the vision has deteriorated on the right side to the point where i need glasses for both distant and near vision. We have tried every type of therapy for the dry eye with no success. Before the surgery i told dr that my eyes were too dry for me to wear contact lenses. He performed a tear test and told me that although my eyes were on the dry side of normal, i was a good candidate. That has proved not to be the case. In my opinion, if eyes are too dry for contact lens wear, that should be a serious warning sign that there may be dry eye problems after lasik. If i had to do it over again i would not do lasik. A recent tear test performed by dr shows that the tear production in the right eye is unchanged from prior to surgery, but tear production in the left eye is less than half what it was prior to surgery. In addition, although it's a minor problem, at night i no longer have the very sharp vision had with glasses. Stars do not appear as single dots of light, but have a slight star-burst appearance.

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Brand NameNA
Type of DeviceLASIK
MDR Report Key1578295
Report NumberMW5014315
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/11/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2010
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: 01/11/2010 Patient Sequence Number: 1