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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK NONE

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LASIK NONE Back to Search Results
Event Date 08/23/2007
Event Type  Injury  
Event Description

Dr. Performed my lasik in 2007. After the procedure, i developed chronic dry eye. I hadn't had this problem before the procedure and was not warned about it prior to the procedure. I went back to dr. Norden and he inserted plugs in my tear ducts and explained that women over 40 tend to have this problem. I would liked to have been warned beforehand so i could have made a more informed decision about this procedure. Now, over a year later, i still have plugs in my tear ducts and wake up in the middle of the night with difficulty opening my eyes and have to put drops in to be able to sleep. My eyes are sore, very dry, and puffy in the morning and i'm concerned about the long-term effects. I have been given a prescription for restasis but am afraid of forming a dependency. I thought that after all these years this procedure had been perfected and i knew all of it's shortcomings, and i'm very disappointed with the results. With all the problems, i would at least have hoped that i would have come out of it with perfect vision, but that was not the case. Dr. Offered to do the procedure again to fix my vision, but i'm afraid my eyes will just turn to dust if i take him up to it.

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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1216517
Report NumberMW5008812
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/29/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Date Received: 10/29/2008 Patient Sequence Number: 1