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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 Blurred Vision (2137); Visual Impairment (2138)
Event Date 07/21/2001
Event Type  Injury  
Event Description

I had lasik at (b)(6), surgery performed by dr (b)(6). After the first surgery on (b)(6) 2001, a week later, things went blurry and night vision problems. After nearly 3 months later, an enhancement was performed; however, problems still persisted, and made it worse. Post op care was very poor, the operating surgeon, dr (b)(6), did not even have the courtesy to see me afterwards. Now 10 yrs later, i suffer from lasik ectasia/keratoconus.

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Brand NameNA
Type of DeviceLASIK
MDR Report Key2190642
MDR Text Key2131877
Report NumberMW5021565
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 07/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Is The Reporter A Health Professional? No

Date Received: 07/29/2011 Patient Sequence Number: 1