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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Device Problem Insufficient Information (3190)
Patient Problems Corneal Edema (1791); Loss of Vision (2139)
Event Date 01/01/2011
Event Type  Injury  
Event Description

Post-lasik ectasia. I had lasik surgery in 2004. My vision was excellent for 4 years. Then i began to notice that the sight in my left eye was beginning to degrade. Finally in 2010, i needed to get glasses again. At the end of 2010, i became concerned at how fast my glasses were no longer strong enough. I was needing a new prescription around every six months, but this time, i noticed a problem just two months after my last new pair of glasses. My eye doctor suggested that i might have keratoconus and referred me to an ophthalmologist, who confirmed that i was likely experiencing post-lasik ectasia, not keratoconus. I have since gotten hard contacts, as my vision can no longer be fully corrected with glasses. My insurance refused to pay for them, so i had to pay (b)(6) out of pocket for them. Just in the couple of months that have gone by in the fitting process, it appears that my left eye has degraded even more. I am very concerned that i will eventually need a corneal transplant. (b)(6).

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2264099
MDR Text Key16538354
Report NumberMW5022344
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 09/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 09/19/2011 Patient Sequence Number: 1