MAUDE Adverse Event Report: SMILE LASER VISION CORRECTION; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Patient Problems Dry Eye(s) (1814); Headache (1880); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/20/2023

Event Type  Injury  

Event Description

Smile laser vision correction surgery was performed.I've had vision blurriness, dryness, double vision, difficulty seeing and driving, headaches.

• Brand Name: SMILE LASER VISION CORRECTION
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• MDR Report Key: 17975684
• MDR Text Key: 326267390
• Report Number: MW5147173
• Device Sequence Number: 1
• Product Code: OTL
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White