MAUDE Adverse Event Report: LASIK WAVE FRONT LASER; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Anxiety (2328); Depression (2361); Dry Mouth (4485)

Event Date 01/22/2020

Event Type  Injury  

Event Description

Had lasik done and immediately after experienced the worst pain of my life like someone doused my eyes with gas and lit them on fire.I had a red lesion on my right eye that took a couple months to heal.About a months after lasik i started experiencing debilitating headaches and bad dry eye that has continued to get worse.I now deal with this eagerly day of my life and a lot of my saving have been drained due to medical bills.I also have very low quality of life and deal with depression and anxiety.Lasik is a dangerous procedure and should never be okay.This procedure should be taken off the market.Fda safety report id # (b)(4).

• Brand Name: LASIK WAVE FRONT LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 11453693
• MDR Text Key: 239214502
• Report Number: MW5099901
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): Y
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 35 YR
• Patient Weight: 54