MAUDE Adverse Event Report: LASIK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Visual Impairment (2138); Visual Disturbances (2140); Depression (2361)

Event Date 09/18/2020

Event Type  Injury  

Event Description

My husband had lasik surgery with dr (b)(6) from (b)(6).He has severe dry eyes, vision change, light sensitivity, floaters, no contrast in his vision.Plus he is severely depressed from it.Has to have professional psychological help.Fda safety report id# (b)(4).

• Brand Name: LASIK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 11731672
• MDR Text Key: 247716160
• Report Number: MW5100999
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/22/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 45 YR