MAUDE Adverse Event Report: LASIK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Red Eye(s) (2038); Blurred Vision (2137); Visual Impairment (2138); Halo (2227)

Event Date 10/10/2021

Event Type  Injury  

Event Description

I had my lasik surgery on (b)(6) 2021 and then next day i had a lot itching and redness in my eye after that day by day my vision gone worse.Now i'm suffering from double vision, blurred vision and halos.Doctor says that i have ctk = central toxic keratopathy.There is no improvement in my vision and life is getting worst.No idea what to do and can't live with this distorted vision.(b)(6).

• Brand Name: LASIK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12852610
• MDR Text Key: 281196555
• Report Number: MW5105502
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/18/2021

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: 11/19/2021
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian