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

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/16/2018 Patient Sequence Number: 1