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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK LASIK

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LASIK LASIK Back to Search Results
Lot Number LASIK
Event Date 03/01/2004
Event Type  Injury  
Event Description

I had lasik surgery on both eyes and immediately had severe dry eyes, halos, ghosting, double vision and headaches. I have spent the past six years with over 11 doctors with minimal relief. In the interim, i developed a cataract in one eye due to steroids used as a potential solution for my problems. The cataract healing process took almost one year and has left my eye in much worse condition. I now am left with only one third of my eye that i can only occasionally see out of properly. This is like a film over my eye that gets much worse with high humidity. My current condition finds me waking 5-6 times per night to 'un-stick' my eyes with specialized eye lubricant. I have found no lubricant that has worked well and am constantly searching for an answer. I am also developing a new pain in my left eye deep within. The reason for this is unk at this point.

 
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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
LASIK
MDR Report Key1823500
Report NumberMW5017271
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/27/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT NumberLASIK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 08/27/2010 Patient Sequence Number: 1
Treatment
LASIK SURGERY
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