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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY

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LASIK SURGERY Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Cataract (1766); Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138)
Event Date 04/01/2014
Event Type  Injury  
Event Description
I had lasik surgery on both eyes in (b)(6) 2012. By (b)(6) 2013, the sight in my left eye began to greatly deteriorate and my lasik surgeon performed an enhancement that did not work. I began experiencing cloudiness and pain in my left eye. When i went back he told me that i had an aggressively growing cataract in my left eye. I am only (b)(6) and i am scheduled to have the cataract in my left eye removed next week, i have also suffered from extreme dry eye since the lasik surgery. I am extremely disappointed that this was not mentioned as a possible complication from the lasik surgery. Had i known i could possibly develop cataracts, i would not have elected to have the lasik procedure.
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Type of DeviceLASIK
MDR Report Key3731808
Report NumberMW5035471
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Age45 YR
Patient Weight88