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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPHTHALMIC FEMTOSECOND LASER

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OPHTHALMIC FEMTOSECOND LASER Back to Search Results
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.
 
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Brand NameOPHTHALMIC FEMTOSECOND LASER
Type of DeviceOPHTHALMIC FEMTOSECOND LASER
MDR Report Key7200333
MDR Text Key97667115
Report NumberMW5074631
Device Sequence Number0
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
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 Received01/16/2018
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
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