MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Retinal Detachment (2047); Retinal Tear (2050)

Event Date 08/10/2022

Event Type  Injury  

Event Description

I underwent lasik surgery in 2003.In august 2022- january 2023 i've had 6 retinal tears and 2 retinal detachments.I've undergone 3 in office laser procedures and one surgery to repair the tear and detachment.They placed a buckle in my right eye to repair.Dr.(b)(6).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 16386795
• MDR Text Key: 309774878
• Report Number: MW5114996
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: WELBUTRIN
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White