MAUDE Adverse Event Report: UNKNOWN LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Headache (1880); Pain (1994); Inadequate Pain Relief (2388); Eye Pain (4467)

Event Date 11/22/2008

Event Type  Injury  

Event Description

I had lasik done back in 2008.I was told i was a "perfect" candidate.From day one after lasik i developed severe dry eyes that never went away.I have constant eye discomfort everyday of my life, my eyes are always dry, i get headaches due to eye pain and i also will have facial pain.I have almost exhausted every treatment there is for my condition with little to no help with controlling my pain/dry eyes.Up until a year ago i was diagnosed with corneal ocular pain.Which i didn't know was a thing.To this very day i'm still trying to manage these life changing complications i have from lasik surgery.Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15894569
• MDR Text Key: 304740387
• Report Number: MW5113570
• 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: 11/28/2022

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: 11/30/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White