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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
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Corneal Clouding/Hazing (1878); Blurred Vision (2137); Visual Impairment (2138); Vitreous Detachment (2445)
Event Date 06/06/2014
Event Type  Injury  
Event Description

In (b)(6) 2008, i had lasik. Two years later, i had a posterior vitreous detachment in the left eye and now six years later, i have had a posterior vitreous detachment in the right eye. I have very large black floaters in both eyes and a haze or cloudy area in both eyes that make it impossible to focus clearly. Glasses will not correct this because the cloudiness is in my vitreous. I was myopic presurgery with both eyes being about a -6 dpt. Nobody advised me that this could be a side effect. I now feel like i am partially blind. I've also been on restasis for six years and have just switched to a autologous serum eyedrops for my dry eye. The eyedrops have improved the health of my cornea but it does not help with the posterior vitreous detachment. If only i had a time machine to go back and not choose this surgery. Why wasn't i told this could be a risk. Now i worry in the next few years what the next surprise will be from this nightmare of a surgery called lasik. I don't understand why it is legal.

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key3926579
MDR Text Key4580373
Report NumberMW5037097
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER

Patient TREATMENT DATA
Date Received: 07/07/2014 Patient Sequence Number: 1
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