MAUDE Adverse Event Report: WAVEFRONT LASER; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Inflammation (1932); Pain (1994); Red Eye(s) (2038); Loss of Vision (2139); Excessive Tear Production (2235)

Event Date 07/30/2015

Event Type  Injury  

Event Description

Had lasik performed on (b)(6) 2015 at tlc.Approximately 1 hour after procedure was performed, i experienced excruciating pain in both eyes.Pain stopped when i used steroid drops (per dr.'s order) upon coming home.I was checked regularly by my eye dr who said i was progressing as expected.Vision was fine for the first two weeks when suddenly i experienced issues with my vision that made it difficult to see clearly.After many thousands of dollars spent on numerous treatments - including two rounds of stem cell therapy (prokera) in both eyes, restasis, lotemax, pred forte, xiidra, hundreds of dollars spent on preservative-free eye drops, i am still experiencing issues with very dry eyes.I went back to tlc for help and was prescribed restasis, which initially helped.The dr seemed satisfied with how i was doing, told me it would take up to 3 months to experience the full benefit of the restasis and told that if i had further issues to go to my eye dr.At both visits to tlc, they were aware of the issues i was having and not once was any extensive testing done to determine what was wrong with my eyes.I was slightly better at the three-month mark and wanted to give my eyes more time to see if they would improve, but i was back at my eye dr.Within a few months.At that time, and after running additional tests, it was determined that my corneas had not healed properly and were not attached as they should be.This came as a complete shock to me, especially after going back to where i had the lasik done and not being told this information.After much discussion with my eye dr., i decided to undergo prokera, which worked and my vision was perfect for approximately 1 month.Just as suddenly as my vision worsened after lasik, the same thing happened after prokera.Luckily, my insurance allowed me to undergo treatment, an additional time and my vision wasn't as crisp and clear as it was after the first treatment, my vision and comfort level had improved and my corneas had stabilized.Shortly after my prokera treatment, xiidra became available on the market and i began to take that.It helped significantly for the first 6 months and then my eyesight began to worsen once again due to excessively dry eyes.At that time, i began to use xiidra in conjunction with restasis and my eyes became less dry and my comfort level had improved enough that i could see fairly well and my eyes were not red and painful.After a year on both drops, my eyes became red and began to tear excessively.It was discovered that my tear ducts became blocked due to inflammation from my chronic dry eyes.I was put on a regiment of pred forte for a month, along with my prescription eye drops, where i would start with 4 drops a day and taper down to one.Within 2 days of stopping the treatment, my eyes became red and began to tear excessively once again.I am currently on pred forte for a second course.I pray it works this time because pred forte cannot be used long term due to risk of glaucoma.

• Brand Name: WAVEFRONT LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 7889614
• MDR Text Key: 120968019
• Report Number: MW5079905
• 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: 09/15/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 61