MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Headache (1880); Pain (1994); Anxiety (2328); Discomfort (2330); Depression (2361); Increased Sensitivity (4538)

Event Date 09/23/2017

Event Type  Injury  

Event Description

I had lasik in (b)(6) 2017 during the (b)(6) holiday in (b)(6).I was anxious about it (the idea freaked me out), but pushed those anxieties down, as i told myself that if the doctor said i wasn't a good candidate, or if there were going to be any special things i had to do to prepare my eyes, i would back out.The doctor said i was a perfect candidate, and that the dry eye wasn't an issue.I had passed the strip test they give you to test for tear production.He told me i would only experience elevated dryness for a few weeks post-op.So i scheduled an appointment.(they actually perform so much lasik in (b)(6), that you can receive surgery the same day as your consult, but i wanted time to prepare.) during surgery, the doctor had trouble getting the machine to make the cut in my cornea.He had to call on a senior doctor for help.I apparently had scarring on my cornea that they missed during my consult, which made the cut more difficult.I had a massive anxiety attack, but was too afraid to ask them to stop.I wish i had now.I have never experienced the pain i experienced post surgery.The dryness was unbearable, and the light sensitivity was horrendous.I could barely make it through the school day.The doctor told me that the headaches i was experiencing were not related to lasik (insert massive eye roll here) and recommended i see a neurologist.He also told me i did not have dry eye, and he would be able to tell if i did.I went and saw a different eye doctor, who told me i had horrible and obvious dry eye.When i came home to the states, an eye doctor here re-affirmed that my eyes were so dry they were actually chapped.He put in plugs (which have long since fallen out and haven't been re-inserted), and told me my eye lids actually don't close all the way.This is likely what caused my dryness and corneal scarring.I actually have to now use medical tape to close my lids at night after putting in ointment.I also use goggles to sleep, and use systane ultra drops with no preservatives about every 10-15 minutes throughout the day.Sometimes more when my eyes are acting up or the winter is causing more pain and dryness.I can get through my day without debilitating pain most of the time, but i never feel "normal." i'm always aware of my eyes and their discomfort.I have to use ointment during the day if my eyes are feeling especially painful, and i use a humidifier constantly.I use peppermint oil on my brow bones when the dryness causes frequent sinus headaches.Naturally, i'm anxious about what complications could arise for me in the future.I'm depressed when i think about what i've lost.Lasik has ruined my eyes and i now find it to be a disgusting business meant only for the doctor's profit.Fda safety report id# (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12745556
• MDR Text Key: 280479021
• Report Number: MW5105115
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• 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: 10/29/2021

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: 11/02/2021
• Patient Sequence Number: 1
• Treatment: 10 MG CETIRIZINE HYDROCHLORIDE (ANTIHISTAMINE); CURRENTLY USING AUTOLOGOUS SERUM TEARS PRESCRIBED BY MY DRY EYE SPECIALIST. HAVE ONLY USED FOR ABOUT 4 WEEKS.; OMEGA 3 FISH OIL; SYSTANE ULTRA ARTIFICIAL TEARS
• Patient Outcome(s): Disability
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White