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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Neuralgia (4413)

Event Date 05/09/2021

Event Type  Injury  

Event Description

Got lasik eye surgery on (b)(6)2021; one week later ended up in the hospital with severe ocular pain.Got diagnosed with corneal neuralgia at mass eye and ear ed.This is the worst pain of my life and it continues 5 months later.Fda safety report id# (b)(4).

• Brand Name: LASIK EYE SURGERY LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12467350
• MDR Text Key: 271683727
• Report Number: MW5103913
• Device Sequence Number: 1
• Product Code: LZS
• 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: 09/09/2021

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?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability