MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Headache (1880); Pain (1994); Tinnitus (2103); Halo (2227)

Event Date 11/13/2020

Event Type  Injury  

Event Description

I had laser eye surgery and developed many complications after this.Extreme eye dryness, headaches, halos, tinnitus, eye pain and a lot more.The company lasik md isn't helpful with my case.Fda safety report id# (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 13237830
• MDR Text Key: 283784806
• Report Number: MW5106614
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/07/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2022
• Patient Sequence Number: 1
• Treatment: MAGNESIUM ; OMEGA 3; VITAMIN D ; ZINC
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White