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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATIONWIDE VISION LASIK EYE SURGERY

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NATIONWIDE VISION LASIK EYE SURGERY Back to Search Results
Event Date 05/15/2010
Event Type  Injury  
Event Description

Prior to lasik surgery, i never had a problem with dry eyes. They explained that any risks associated with lasik eye surgery is very rare, although i believe i did sign a consent related to this. Now, post-lasik and 7 months later, my left eye is continuously blurry. I see stars around car lights and halos at night. Some days are so bad, i can't see anything clearly at all. The doctors at nationwide have told me that i have "dry eyes", and that part of my cornea is "sloughing off" due to the dryness, in the cornea. This sloughing is causing a film over my left eye, and therefore prescription glasses wouldn't even help. The right eye is also dry, but not as bad as the left. I also have headaches frequently, which i never did before the surgery. They are now telling me i have to use eye drops every 30 minutes to 1 hour on a daily basis, and that it should get better. What i'm reading though is that this could be permanent, and this really scares me. (b)(6).

 
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Type of DeviceLASIK EYE SURGERY
Manufacturer (Section D)
NATIONWIDE VISION
MDR Report Key1908898
Report NumberMW5018289
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/19/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2010
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? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 11/19/2010 Patient Sequence Number: 1
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