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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DO NOT KNOW LASIK

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DO NOT KNOW LASIK Back to Search Results
Event Date 06/13/2007
Event Type  Injury  
Event Description

I went to the office of dr to get information on the new procedures for correcting vision loss. His staff gave the eye tests necessary for lens implants. He arrived at the office and said three different times during his 10 minutes that i was perfect candidate for the lens transplants. They insisted on collecting the fees for both eyes at that time. The operation was set for my left eye in 2007. I had the left eye operated on and after i came out of recovery one of his workers checked my eye and became very excited and insisted i go to the retina center. Another dr would not tell me the problem. I tried contacting first dr several times, but was never allowed to speak to him. Several things were tried but to no avail. Second dr performed an operation to correct the problem but it failed. All this time and still no answer to my questions as to what the problem was. Finally in 2008, i picked up my records and went to dr(third). After reading the various reports, he told me that in the first operation by first dr, the macular was left folded. The second operation was to correct the problem but the macular was wrinkled and nothing else could be done. So now i have very poor vision in my left eye and i'm back in glasses. I did not go thru this because of vanity. I am in the early stages of alzheimer's and know how hard it is to keep up with the glasses. By the way, when i picked up my records from first dr, the office person said "he is very sorry about this but the eye was cloudy and he couldn't see the problem. " he makes his staff lie for him. After several calls he did return he was holding for the right eye. According to advertisements, first dr is supposed to be the best qualified in the country. To this day he has never spoken to me after the initial interview when he told me three different times "you are a perfect candidate. " thank you. I hope this helps in your survey!!!.

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Type of DeviceLASIK
MDR Report Key1175747
Report NumberMW5008407
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/24/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Date Received: 09/24/2008 Patient Sequence Number: 1