• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

LASIK Back to Search Results
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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
Type of Device
MDR Report Key5113126
MDR Text Key27204491
Report NumberMW5056601
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/29/2015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age27 YR
Patient Weight75