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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 06/01/1999
Event Type  Injury  
Event Description

I had lasik and it resulted in permanent halos, loss of night vision, and dry-eye. The dry-eye is mild and has improved with time, but has continued. The halos and night vision are severe. I have larger than average pupils, and i've been told that the problem is that they expand to be larger than the surgical scar, which causes light to refract and cause a halo or aura around lights or light-colored objects in dim light. Dim light basically means anything less than very bright sunlight. I used to have unusually good night vision, and it's far more limited now, that's what i regret the most. My measured vision regressed after the fact, but i expected that - it was very bad before. I still wear glasses, but at a much lesser prescription. I don't count that as an adverse reaction, but i do think that many people don't realize that if you have terrible vision to begin with you are less likely to get perfect vision from the surgery. I did know that and accepted it. Due to the halos, i could not drive at night for years, and i only risk it now because i've been able to get much better anti-glare for my glasses that helps a lot. The major problem that i have now is that i can't read street signs until i'm very close because the white wording blurs due to halos. Also, pupils shrink as you age, so that may have helped. My doctor spent a lot of time with me and was very thorough before and after - i don't blame him for this problem. I was warned that i had a higher likelihood than normal to get the long-term halo effects, but was also told it was unlikely. I did not know exactly what the halos wee, and i do not think people realized how likely they were with my type of eye structure at the time. The halo effect and loss of night vision have had a permanent adverse effect on my life and ability to function. I think people should be warned about how troublesome this is, and that there should possibly be stricter guidelines against people with large pupils having this surgery, at least until they figure out how to lessen the chances of this happening. Maybe some sort of drawing or film could be made showing what they might end up seeing at night to explain what the halos are could help. My doctor was very careful about measuring how thick my corneas were before agreeing to do the surgery - maybe pupil size should be an add'l first check. Lasik surgery, 1999.

 
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Type of DeviceLASIK
MDR Report Key1037803
Report NumberMW5006584
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
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
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/01/2008 Patient Sequence Number: 1
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