MAUDE Adverse Event Report: UNKNOWN PRK LASIK; EXCIMER LASER SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dry Eye(s) (1814); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 02/15/2018

Event Type  Injury  

Event Description

I had prk lasik done to both eyes in 2018 as i was told i had developed an eye allergy.Had they done further testing they would have told me i'm not a candidate for lasik as i have dry eyes.Since the procedure i have suffered from severe dry eyes which has no cure.I'm required to get drops several times a day, and use xiidra which with my insurance is still (b)(6) every 3 month and it only helps a little.The clinic said it will improve in time and my eyes will continue to heal.Over 2 years later and i still have issues of burning, redness, eye tiredness.Fda safety report id #: (b)(4).

• Brand Name: PRK LASIK
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10276012
• MDR Text Key: 199222019
• Report Number: MW5095532
• 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: 07/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 170