MAUDE Adverse Event Report: EXCIMER LASER SYSTEM; LASIK LASER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Abrasion (1789); Purulent Discharge (1812); Dry Eye(s) (1814); Loss of Vision (2139); Visual Disturbances (2140); Depression (2361); Inadequate Pain Relief (2388); Suicidal Ideation (4429); Eye Infections (4466); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 01/04/2023

Event Type  Death  

Event Description

This report pertains to the excimer laser used to perform lasik eye surgery.I am reporting the suicide a lasik patient named (b)(6).This is what happened in her own words: quote: i had lasik surgery in (b)(6) 2019 and it has destroyed my life.I have been suffering with not only bad vision that can only be corrected with scleral lens (very expensive and uncomfortable) but the pain in the has been indescribable.I tried committing suicide because no pain medicine can help.My doctor told me i was the perfect candidate for lasik and never talk at all about the risk.I went to one of the so call best so i trusted him.Eight months after the procedure, i woke up one day with swollen eyelids, 3 chalazions and 1 stye.At the time i didn't know what was going on, my doctor dismissed it and gave me a steroid ointment and said it will go away.In the meantime, he convinced me to do what he called an enhancement or touch up because my vision went from 20/20 to 20/40.He was very persistent in convincing me to do this, again being one of the top lasik doctors i agreed.My eyelids had healed somewhat but still had some swelling.I asked him about it and he said "don't worry it' almost gone".I did the procedure and the following day i couldn't see out my left eye.The flap apparently moved and now the real problems started.I had to have 3 stitches to keep the flap in place for 4 weeks.After he removed the stitches, my vision was distorted.He sent me home and told me it will get better.A week later, i told him something is wrong.He did a test and apparently there was a fold or straie which means he did not smooth the flap, it was malposition.He put a contact in my eye and said to wear it for a week and it will smooth itself out.In the meantime my eyelids are more swollen and i had pus leaking from glands and my eyes were extremely dry.The following week he said i had ingrown cells and he needed to refloat cornea.This time i had five stitches for four weeks.It wasn't until i found a dry eye specialist that i realized he did this so called enhancement when i had meibomian gland dysfunction.It's like he used me as an experiment.He knew about it and didn't tell me.People think (as i did) that because lasik surgery has been around a long time it has been perfected and is safe.Not true.I cannot drive at night anymore, i have ghosting images, i suffer from depression, my eyes are sensitive to light, i have blepharitis (never had this in my life) before lasik and i suffer from severe pain.I can't hardly wear my scleral lens because my eyelids are always swollen and in pain.I am not the same person, i was always social and ran all the errands.Now i'm a recluse in my own home and spends hours in bed with pain.My husband is older and has health problem and he has been doing all the errands.There is not a day that goes by that i don't regret this decision and there is not a day that goes by that i don't have suicidal ideations.My doctor also made me monovision without my permission.Not one lawyer would take my case.I wonder how many people have killed themselves after lasik? i guess we will never know.I fully support new labeling for lasik lasers with full disclosure of the risks.End quote.Please help people like me.End quote.

• Brand Name: EXCIMER LASER SYSTEM
• Type of Device: LASIK LASER
• MDR Report Key: 16157516
• MDR Text Key: 307287643
• Report Number: MW5114317
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female