MAUDE Adverse Event Report: LASIK EYE SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Visual Disturbances (2140); Halo (2227); Eye Pain (4467)

Event Date 01/20/2017

Event Type  Injury  

Event Description

Had lasik eye surgery, and had constant pain for years.I also had glare, halos and starbursts.

• Brand Name: LASIK EYE SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 16158032
• MDR Text Key: 307497716
• Report Number: MW5114324
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White