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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 Device Operates Differently Than Expected (2913)
Patient Problems Dry Eye(s) (1814); Headache (1880); Pain (1994); Visual Impairment (2138); Phototoxicity (2165); Halo (2227); Anxiety (2328); Depression (2361); No Code Available (3191)
Event Date 03/01/2010
Event Type  Injury  
Event Description

Six years post-lasik, my wife was diagnosed with corneal ectasia after developing severe headaches, severe dry eye, and severe eye pain and vision problems (distortions, halo, extreme photosensitivity, shadows, ghostings, loss of night vision, and more); she lost her job as an it professional because she was unable to perform duties as a result of these issues, developed severe depression and anxiety and was suicidal; she has not recovered emotionally from the catastrophic outcome of this procedure.

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key6311002
MDR Text Key66810441
Report NumberMW5067723
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
Type of Report Initial
Report Date 02/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2017
Is This An Adverse Event Report? Yes
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Date Received: 02/07/2017 Patient Sequence Number: 1