MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Headache (1880); Vitreous Detachment (2445)

Event Date 01/25/2021

Event Type  Injury  

Event Description

I had lasik surgery performed this year 2021 two days later i noticed two floaters.Two weeks later i started experiencing headaches and increase in floaters.I then went to the ophthalmologist at the center where i received the lasik and was told my eyes were dry and to keep using drops.The following week i decided to see a separate ophthalmologist who performed a dilated examination and found a vitreous detachment he said that was a cause of the suction ring from lasik.Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 11337703
• MDR Text Key: 232621787
• Report Number: MW5099433
• 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: 02/12/2021

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: 02/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 70