MAUDE Adverse Event Report: LASIK MACHINE; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Neuralgia (4413)

Event Date 08/06/2016

Event Type  Injury  

Event Description

Cornea neuralgia; had disability from (b)(6).Fda safety report id# (b)(4).

• Brand Name: LASIK MACHINE
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12467328
• MDR Text Key: 271683204
• Report Number: MW5103912
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: CA
• 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
• Was Device Available for Evaluation?: No
• 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): Other; Disability
• Patient Age: 29 YR