MAUDE Adverse Event Report: UNKNOWN LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Eye Pain (4467)

Event Date 03/23/2007

Event Type  Injury  

Event Description

I just read an article in which patients had complications with lasik surgery as i did in 2007.Until now i thought that my problems with the surgery were only something that happened to me.Now i find that it has also happened to others i had the lasik surgery performed in canada in 2007.For 3 weeks after the surgery, i could not see well enough to drive.During this time, i also suffered with dry eyes, so dry that when i woke up in the mornings my eye lid was frozen to my eyeball! i spent numerous times at the ophthalmologist severe pain, driving was dangerous because one eye or the other was useless until treated with lubricants and pain relievers.Subsequently i refused to pay for the surgery and won the case! l had to use lubricants in my eyes all day long for over five years.After the fifth year i only needed eye lubricants before bed.Had i know of these side effects prior to the surgery i would never had it done! the lasik surgery may be more difficult/side effects with older persons.I was 64 years old when i had it done.People should be warned about the possible side effects prior to the surgery.

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15995357
• MDR Text Key: 305746234
• Report Number: MW5113838
• 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: 12/07/2022

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2022
• Patient Sequence Number: 1
• Treatment: THERA TEARS, EXTRA DRY EYE THERAPY, LUBRICANT EYE DROPS.
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic