MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Neuralgia (4413)

Event Date 01/01/2013

Event Type  Injury  

Event Description

I have corneal neuralgia from lasik.It is extremely uncomfortable on a daily basis and limits my capacity to work a full day or enjoy activities at night.Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 13252337
• MDR Text Key: 283943872
• Report Number: MW5106643
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/10/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White