• 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
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 NameLASIK
Type of DeviceLASIK
MDR Report Key5113126
Report NumberMW5056601
Device Sequence Number1
Product CodeLZS
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 Received09/29/2015
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/29/2015 Patient Sequence Number: 1
-
-