MAUDE Adverse Event Report: LASIK

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.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 6311002
• MDR Text Key: 66810441
• Report Number: MW5067723
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR