MAUDE Adverse Event Report: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Patient Problems Corneal Edema (1791); Dry Eye(s) (1814); Visual Impairment (2138); Depression (2361); Eye Pain (4467)

Event Date 03/28/2023

Event Type  Injury  

Event Description

Relex smile in both eyes with -4.5 myopia.Corneal neuropathic pain, dry eyes, starbursts, halos, glare,ghosting after surgery.Vision is very bad.Almost not able to continue career as it consultant.No surgeon is able to help or doesn't want to.Life ruined.Not enough informations about the complications of those surgeries.I need therapy after surgery for mental health and depression.

• Brand Name: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• MDR Report Key: 18447059
• MDR Text Key: 332147697
• Report Number: MW5149793
• 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: 01/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White