MAUDE Adverse Event Report: OPHTHALMIC FEMTOSECOND LASER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitreous Floaters (1866); Pain (1994); Loss of Vision (2139); Anxiety (2328); Vitreous Detachment (2445); Sleep Dysfunction (2517); Weight Changes (2607)

Event Date 01/15/2018

Event Type  Injury  

Event Description

I had relex smile surgery with femtosecond laser on (b)(6) 2017 at (b)(6), (b)(6).On about (b)(6), i noticed several large black cobweb floaters floating in one eye.I was never told that this was a potential side effect.I am now suffering from partial vision loss and it is severely impacting my family and work life.I am only (b)(6) and i never saw these floaters pre-surgery.The surgeon told me that it was a "coincidence" that i got a post vitreous detachment since i was already myopic.In the pre consultation, the surgeon, dr (b)(6) never told me that i was already at risk of getting a pvd.I am deeply upset by this and wish i stayed with my contact lenses.I use a computer daily and am haunted by so many cobwebs floating in my vision in meeting rooms, outside etc.I have had several panic attacks and have had trouble sleeping and have lost weight.The surgery never did a pupil dilation test for my consultation.This procedure should be banned from all clinics until clinics advise pts the risk of getting a pvd or significant floaters after the surgery.I was never informed of this potential side effect.

• Brand Name: OPHTHALMIC FEMTOSECOND LASER
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• MDR Report Key: 7200333
• MDR Text Key: 97667115
• Report Number: MW5074631
• Device Sequence Number: 0
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Weight: 58