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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK; EXCIMER, LASER SYSTEM
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LASIK; EXCIMER, LASER SYSTEM Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138); Twitching (2172); Dizziness (2194); Halo (2227); Depression (2361)
Event Date 12/03/2016
Event Type  Injury  
Event Description
I had laser eye surgery in (b)(6) 2016.I now suffer from chronic dry eye.The impact of this on my life has been absolutely massive.I am in severe pain most of the time.I suffer from excessive tears which means i cannot see clearly, i experienced a pvd, i now also have mgd.I see halos and starbursts at night and wake up each morning to immense pain.I am struggling to keep my job in the civil service in the (b)(6) as i experience an increase in pain as well as eye twitches and dizziness if i read from paper or screen.The text also curls at the edges.Depression has set in which has led to the loss of my 7 year relationship.I am (b)(6), my quality of life has severely reduced.I have no idea how i will continue supporting myself if i lose my job.We only live once; please do the right thing and take steps to stop laser eye surgery.It is ruining far too many lives and presented as a safe procedure.This procedure needs to stop.
 
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Brand Name
LASIK
Type of Device
EXCIMER, LASER SYSTEM
MDR Report Key8531808
MDR Text Key142731554
Report NumberMW5086013
Device Sequence Number1
Product Code LZS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age31 YR
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