MAUDE Adverse Event Report: LASIC/PRK OPERATION; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Disturbances (2140); Halo (2227); Unspecified Eye / Vision Problem (4471)

Event Date 04/05/2017

Event Type  Injury  

Event Description

I got lasik eye surgery done to my eyes.I have got so many eye complications that i feel like disabled.I was never told or informed about these after affects.These include starburst, floaters, halos, eye strain, dry eyes and a lot others.This procedure must be stopped immediately.Fda safety report id# (b)(4).

• Brand Name: LASIC/PRK OPERATION
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 15085989
• MDR Text Key: 296511711
• Report Number: MW5111070
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian