MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Depression (2361)

Event Date 07/25/2011

Event Type  Injury  

Event 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
• Type of Device: LASIK
• MDR Report Key: 5113126
• MDR Text Key: 27204491
• Report Number: MW5056601
• 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
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 75