MAUDE Adverse Event Report: EXCIMER LASER; EXCIMER LASER SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Halo (2227)

Event Date 02/04/2022

Event Type  Injury  

Event Description

Smile and lasik surgery was performed on my left and right eye respectively on friday, (b)(6) 2022.In (b)(6), i had cataract surgery in my right eye which was mildly corrective.A year later, my vision is worsening with visual symptoms including halos, starbursts, glare, and ghosting.I have severely dry eyes and i am required to use glasses for distances and readers.

• Brand Name: EXCIMER LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 16325951
• MDR Text Key: 309196812
• Report Number: MW5114785
• Device Sequence Number: 1
• Product Code: OTL
• 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: 02/04/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American