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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138)

Event Date 07/15/2020

Event Type  Injury  

Event Description

I had lasik surgery done and now i have had extreme dry eyes for the last year.I have horrible night vision for driving.My vision has been fluctuating and some days it has been hard to read the computer to work.Fda safety report id # (b)(4).

• Brand Name: LASIK EYE SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12307846
• MDR Text Key: 266367437
• Report Number: MW5103175
• 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: 08/06/2021

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: 08/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR