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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK EYE SURGERY LASE OPTHALMIC

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LASIK EYE SURGERY LASE OPTHALMIC Back to Search Results
Event Date 05/01/2007
Event Type  Injury  
Event Description

Had lasik eye surgery in (b)(6) 2007. Since then, i have severe dry eyes always requiring eye drops and also halos around lights at night time. In addition, in only a few years my vision degraded to the point of needed glasses again, completely nullifying the purpose of the surgery. In addition i feel it was not fully explained how the corneal flap never fully heals, and only heals to a few percent of the original strength. I knew the vision may worsen (though they said more like 30 years), but did not know if never fully heals. That alone as i am into sports etc, would have enough to skip the procedure. In addition, my night vision is worse, halos over lights, and computer screens always look out of focus for whatever reason as well. I fell i traded 3 years of decent vision for a whole list of other issues in addition to my "old" vision returned in only 3 years.

 
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Brand NameLASIK EYE SURGERY
Type of DeviceLASE OPTHALMIC
MDR Report Key3934355
Report NumberMW5037238
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/09/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER

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