MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Depression (2361)

Event Date 01/05/2018

Event Type  Injury  

Event Description

I have had increasing onset of depression and lack of desire to perform daily or recreational activities, starting after having lasik surgery.I have been searching for what changed in my life and recently discovered that this is a common side effect of the procedure.I still have dry eyes, foggy vision, and lack of concentration.When i noted effects to doctors during post-op visits, they were calmly dismissed and i was told they would go away.

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 7624704
• MDR Text Key: 112133969
• Report Number: MW5077975
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 82