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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK
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Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes Dry Eye(s) (1814); Headache (1880); Pain (1994); Visual Impairment (2138); Phototoxicity (2165); Halo (2227); Anxiety (2328); Depression (2361); No Code Available (3191)
Date of Event 03/01/2010
Type of Reportable Event Serious Injury
Event or Problem 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 Name
LASIK
Common Device Name
LASIK
MDR Report Key6311002
Report NumberMW5067723
Device Sequence Number16285697
Product Code LZS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/07/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age46 YR
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