MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Eye Injury (1845); Neuralgia (4413); Eye Pain (4467)

Event Date 03/18/2021

Event Type  Injury  

Event Description

I had lasik surgery at (b)(6) center in (b)(6).As a result of my surgery, i have corneal neuralgia in both eyes, which causes constant pain and the inability to complete most daily tasks.I have seen four doctors for this condition and all treatments have failed.This has cost me thousands of dollars and hours of my time.Doctors have told me that i had an underlying condition, myopia gland dysfunction and that i should have been screened for this prior to surgery, as it increases the risk of post-surgical complications.I was never made aware of this prior to my surgery and would've opted out of it if i had been made aware of the risks.Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12137983
• MDR Text Key: 260864996
• Report Number: MW5102396
• 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
• Type of Report: Initial
• Report Date: 07/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 64