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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Type  No Answer Provided  
Event Description

My purpose for this letter is to inform the fda that i believe i belong in the 10% of the population for who lasik surgery did not work. In 2006, i underwent lasik vision surgery on both of my eyes at the location captioned above. Following the procedure, vision in both of my eyes was blurred and fuzzy. After continued complaints, eyeglasses were ordered for me in 2007. However, my sole purpose for getting the lasik done was so that i would not be burdened with having to wear eyeglasses! finally, the lasik vision institute informed me that they would re-do the procedure, but when the day arrived on six months later, after a preliminary visit on six days before, they refused due to cataracts. This was the first time anyone mentioned anything to me about having cataracts. They referred me to another hospital for cataract surgery. The cataract surgery was a success, but i continued to have blurriness in both of my eyes just as i did following the lasik procedure. I notified both the lasik vision institutes of my continued vision problems by certified mail on 11/08/07. A dr from st. Luke's responded and recommended some eye drops to use. They initially seemed to help. I was advised to use them sparingly and i do, but i find now that they do not seem to help clear up my vision. Nobody from the lasik vision institute ever responded to my letter or phone calls. I want to make it known that second hospital has been working with me and that i even have a follow-up appointment schedule with them when i return to florida this fall. I want to emphasize my reason for this letter to place the fda on notice of another failed lasik procedure. If you require any additional info, please contact me.

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key1062570
Report NumberMW5007352
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/03/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No