MAUDE Adverse Event Report: LASER

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Pain (1994)

Event Date 11/18/2008

Event Type  Injury  

Event Description

I got prk surgery when i was in the air force and i regret it.It's been 5 yrs and my eyes constantly hurt and are super dry.When i wake up and my eyes open, it feels like i opened them in chlorine water.I think they are getting worse some days i cannot touch the lid of my left eye.What is worse is still need glasses so all that pain and difficult post-op pain was for nothing.Prior to my surgery, i spoke to a fellow airman who had warned me but i thought it must have been a unique situation and didn't listen to her, so i know i'm not the only one.Now i'm constantly using eyedrops and taking eye vitamins to see if that helps and it does but only so much.The drops help with the dryness, but not the pain.When a group of us were getting the surgery that day, i remember being in a room and being handed a bunch of papers, liability forms i'm sure, and not being explained anything; that day i remember asking if we had to option to getting lasik and i was told no very rudely.I was not at any point explained of the possibility life long effects of prk.

• Brand Name: LASER
• Type of Device: LASER
• MDR Report Key: 3628055
• MDR Text Key: 21527481
• Report Number: MW5034409
• 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: 02/09/2014

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR