MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Loss of Vision (2139); Suicidal Ideation (4429); Eye Pain (4467)

Event Date 05/31/2022

Event Type  Injury  

Event Description

My medical and optometric healthcare providers did not properly screen me for lasik surgery.I had multiple disqualifying conditions at the time, including severe dry eyes and an autoimmune disorder.Following the procedure, i have had debilitating pain in my eyes, lost significant vision, and am now on short-term disability leave from work (fully expecting to transition to long-term disability leave in march).Prior to surgery, i asked my optometrist and my surgeon whether my existing dry eyes could result in complications or should disqualify me from surgery.I was repeatedly reassured that i would not have any problems and that any problems i did experience would be minimal or short-lived.I went from taking two pills a day to over 20 (including eye drops).My life and my significant other's life have become infinitely worse since the surgery the point where i have legitimately considered self-harm and suicide.(b)(6).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 16207829
• MDR Text Key: 307725260
• Report Number: MW5114388
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White