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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY

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LASIK SURGERY Back to Search Results
Event Date 09/09/2009
Event Type  Injury  
Event Description

I had lasik surgery in both eyes in 2002 at the eye clinic. All went well and i had no problems until 2008. My right eye got very blurry- very quickly. I thought it was time for me to go in and have lasik again- or a "tune-up" as they call it. I went to a new doctor because i had moved. He spent a lot of time and took a lot of fancy pictures and said that he thought i had "corneal ectasia". He sent me to a cornea specialist at another facility for a second opinion. The cornea specialist agreed and diagnosed me with corneal ectasia. Both drs said this is caused from the lasik surgery. Dr recommended a clinical trial at the third facility - a crosslinking study for this very diagnosis. I am at this time enrolling in it. I am very concerned though because it is a study and not a treatment. The vision in my left eye is very bad, but there is nothing to improve it at the moment. And i have to travel to atlanta and must pay for all of this on my own.

 
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Brand NameLASIK SURGERY
Type of DeviceLASIK SURGERY
MDR Report Key1578403
Report NumberMW5014338
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 Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/11/2010 Patient Sequence Number: 1
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