MAUDE Adverse Event Report: LASIK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Inflammation (1932); Nerve Damage (1979); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Burning Sensation (2146); Neuralgia (4413); Suicidal Ideation (4429); Increased Sensitivity (4538)

Event Date 10/26/2018

Event Type  Injury  

Event Description

I had severe complications from my lasik surgery.The complications left me with severe inflammation in my eyes even after the majority of dry eye treatments had been tried and a condition called ocular neuropathic pain or corneal neuralgia.My inflammation did not show up on mmp9 and only mildly on the tear osmolarity test.However, once the in vivo confocal microscopy was used, it was clear i had severe inflammation and there were problems with my nerves.Further, my eyes were producing basically zero tears at all and my tear break up time was one.This means my eyes were extremely dry.I had extreme burning in my eyes like i felt like i had sunscreen in my eyes at all times for about 2 years! i had a deep pain behind my eyes that radiated out of the sockets, and a burning in my cheek.It left me extremely light sensitive and unable to look at phones and computers for more than a split second.It made me extremely wind sensitive as well and i am talking about just the very slightest movement of air bothered my eyes immensely.My vision during the day was blurry and doubled and for three months there was a haze over my vision like i was looking through a steamy shower door.My night vision was horrific! every light had starbursts and streaks going across my entire line of vision, the lights dazzled and were extremely bright to me because of my light sensitivity.They caused me a lot of pain.I had suicidal thoughts everyday! in fact, i knew that i could endure the torture for a few years while i spent every penny on finding the solution but beyond that i had every intention of taking my life because being unable to see properly and being tortured indefinitely was not a way that i could live.Trust me when i say i am one of the happiest people and i do not have any mental health issues.I just was tortured that terribly by my lasik surgery and most doctors said i don't know how to help you.Finally i went to dr.(b)(6) and followed his protocol.After 2 years of following his directions that come with a ton of expenses and risks, i have made significant improvements.I believe that at this point i have spent between (b)(6) on remedying the situation and continue to spend money on a lot of dry eye treatments that are not covered by insurance.(b)(6) in (b)(6) said they would give me some money but they never did.At this point, by spending a ton of money and following dr (b)(6) protocol, my vision improved significantly, i still deal with occasional burning and pain but often it is gone, my light sensitivity has basically resolved but i am still wind sensitive and can't be in dry places.My tear film has gone up but more than likely i will be on a lot of eyedrops for the rest of my life that are very expensive.It has taken me two years of following dr (b)(6) protocol to make these improvements.So that's three years after my lasik surgery.I am hopeful for my future but i really don't know what my future holds.I have held off on filing this report because i wanted it to be more complete and for you to know more about the extent of my suffering.I also need to add that out of all of the members of the corneal neuralgia (b)(6) group, i am one of the most lucky ones that has made significant improvements.Most people are not as fortunate as i have been and are still suffering immensely.I wouldn't wish this on my very worst enemy.Fda safety report id # (b)(4).

• Brand Name: LASIK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12658508
• MDR Text Key: 277207797
• Report Number: MW5104708
• 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: 10/16/2021

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: 10/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AUTOLOGOUS SERUM TEARS; BIRTH CONTROL PILLS; LOTEMAX; LOW DOSE NALTREXONE; OMEPRAZOLE; REFRESH PLUS; RESTASIS
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 68