MAUDE Adverse Event Report: PRK LASER; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Headache (1880); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Excessive Tear Production (2235)

Event Date 01/08/2019

Event Type  Injury  

Event Description

I was lied to about the percentage of the side affects of prk post lasik.I ended up with every "less than 1% chance" side affect you could have after prk surgery.I ended up with severe dry eyes, neuropathic pain so excruciating it feels like an ice pick going through the middle of my eye and along with that comes such severe migraines you want to hurt yourself.It's the most unimaginable pain you can think of.You almost, no not almost, it definitely feels like i'm being slowly tortured.And there are days i'm not sure i'm gonna make it through another day.Dr (b)(6) offered to put (b)(6) towards a new pair of glasses to help me see, and now he wants his money back.Wth, are you kidding me? i have had 2 car accidents a week after, i was told i could go back to work and i was seeing double vision.Not much depth perception or peripheral vision, and the sun makes my eyes hurt and endlessly tear up even in sunglasses.Had horrible haze and blurriness.I should not have ever been cleared to drive yet, but they cleared me to work.That should have never happened.I was in no shape to be released to drive and go back to work.My surgery was in january, and it's now june, and he released me from his care because he could no longer help me with my major side affects from his surgery.Don't let them tell you these side affects are less than 1% chance.I've now done my homework a little late in the game unfortunately and these side affects are way more than they tell you.They are more like a 40% chance than a 1% chance.Do your homework folks, it's all a big covered up scam.Look into it folks, you only get one set of eyes.Do your homework even if you think you got the best eye dr in the world.I recommend that you look at "the complications of prk post lasik surgery," on (b)(6).I'm so serious, don't take this lightly and don't believe every eye surgeon had your best interest at heart either.They are there to make money off you.Do you think if they actually told you it was a 40% chance of these side affects that you would go through with the privy? hell no, so they downplay everything.My quality of life is so horrible, some days i feel like my family would be better without me.Im' pissed and i want it fixed, but i can't now.Thanks (b)(6), i appreciate your overall care and concern for my well being, not appreciated.Dr's of eye surgeries must disclose the truth about the percentages of side affects of lasik and prk.I no longer have any semblance of quality of life any longer due to these liars.Fda safety report id# (b)(4).

• Brand Name: PRK LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 8700312
• MDR Text Key: 148328072
• Report Number: MW5087379
• 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: 06/10/2019

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: 06/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Weight: 70