MAUDE Adverse Event Report: LASIK

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Depression (2361)
Date of Event	07/25/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller advised he had lasik surgery at (b)(6) on (b)(6) 2011.Surgeon mentioned potential adverse effects which was supposed to be temporary."my life has been a complete nightmare after the surgery".Caller fell into a deep depression with suicidal thoughts and is currently on medication for depression and also seeing a therapist.Caller is still experiencing night vision problems which include blurred vision, glare, halos, diplopia in the left eye and distorted vision in the right eye (sees four different images when looking at one image) and dry eyes.Caller advised lasik eye surgery is very dangerous and was never warned about the psychological effect the surgery will have on him.

• Brand Name: LASIK
• Common Device Name: LASIK
• MDR Report Key: 5113126
• Report Number: MW5056601
• Device Sequence Number: 501920
• Product Code: LZS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Weight: 75