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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLEGRETTO WAVE, LASIK NONE

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ALLEGRETTO WAVE, LASIK NONE Back to Search Results
Event Date 07/07/2006
Event Type  Injury  
Event Description

I had lasik eye surgery from dr. In 2006. It was the biggest mistake of my life. Here is a list of my concerns: - my last checkup occurred last year, and i still remained at 20/15 on my right eye and 20/20 on my left eye. This is very misleading as things over 20 feet are blurry. They're especially blurry in medium to low lighting. I had no idea that my eyesight was definitely going to be worse afterwards. I thought since 20/20 was very likely, my vision could remain perfect at far from it. My vision also fluctuates depending on how much rest i get. I believe it's because the more i rested i am, the bigger my pupils are. Bigger pupils lead to seeing more through untreated parts. -they only treated my eyes partially and did not warn me of this. The treatment zone simply did not cover my entire eye. I have big pupils. The cut did not go outside of my pupils but within it. The outer area of my pupils remains untreated. I was not warned of this. I just cannot understand how they can get away with something like this as it has severely affected my vision for the worse. -i was not warned that i was going to get a permanent scar on my eyes. I believe it plays a big part of my blurred vision. -i was not warned that my night vision was definitelly going to get worse. I was very shocked the next day to see that my night vision definitely got worse. This should not be a surprise. I was simply warned about the possibility of getting starbursts and halos. I have a severe case of both. Based on the size of my pupils, they should have told me that the likelihood was high. -dry eyes are a constant problem for me. I've experienced loss of sleep and lack of sleep, due to extreme dryness that wakes me up or severe crust formations that did not exist before surgery. I was not aware that there are tests to determine how dry your eyes are. This should be a mandatory test. I have to put several eye drops a day- probably for the rest of my life. This is very costly, embarrassing, and bothersome. - i had red eye for about one month on my left eye. I had no idea that this could happen. It was very embarrassing to have it when i wanted to prove to co-workers and friends that lasik was safe and recommendable, but was i simply showing them proof that i made a mistake. The reputation of my judgement has probably been significantly damaged. -it takes a long time focusing on different distances. If i'm reading something and look up to something, it takes seconds to focus on it. This was always instant before. I was not warned of this. -the stats provided by the media and the ads are absurd. My surgeon asked me if i was glad to have done the surgery the day after. I said i was. He may have put that on record. No one's asked my how i'm doing now. Based on my own personal survey of people having done the surgery, most have regrets. Dates of use: 2006. Diagnosis or reason for use: near-sightedness.

 
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Brand NameALLEGRETTO WAVE, LASIK
Type of DeviceNONE
Device Event Key1264780
MDR Report Key1215203
Event Key1163234
Report NumberMW5008804
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/28/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/28/2008 Patient Sequence Number: 1
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