MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

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

Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138); Suicidal Ideation (4429)

Event Date 07/27/2020

Event Type  Injury  

Event Description

Dry eye and night vision loss after lasik surgery.The dry eye pain is debilitating, it has developed into depression, and suicidal thoughts.Fda safety report id# (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 10927172
• MDR Text Key: 218922898
• Report Number: MW5098143
• Device Sequence Number: 1
• Product Code: NAY
• 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: 11/27/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 23 YR