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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); Emotional Changes (1831); Itching Sensation (1943); Pain (1994); Red Eye(s) (2038); Increased Sensitivity (2065); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Discomfort (2330)
Event Date 09/11/2008
Event Type  Injury  
Event Description
Lasik induced severe dry eye resulting in permanent aqueous and lipid deficient tear film resulting in: burning, itching, stinging, scratching, painful, gritty feeling, eyes feel hot; i can feel my eyelids scraping across my eye balls and contacts when i blink, light sensitive, wind sensitive, cold sensitive, red eyes, blood vessels all over eyes.I am submitting this report in an effort to prevent others from suffering the same tragedy that has befallen myself.I chose to have lasik eye surgery after extensive research and the belief that i could trust medical doctors when they said lasik was safe and side effects were virtually non-existent.I believed in the hippocratic oath.I had lasik eye surgery in (b)(6) 2008 and i believed that everything had turned out ok and would remain this way.I was very badly mistaken.I made it until the spring of 2017 and things started to deteriorate exponentially.The issues were mild to begin with.The medical literature is most definitely correct when they say dry eye disease is a chronic and progressive condition.The situation then very quickly worsened beyond what i thought could be possible.At this point i have tried dozens of treatments worth countless thousands of dollars.Some of them fairly exotic.I have used eye drops made of my own blood, an electrode i had to stick in my nose to elicit a tear response, and nerve growth factor eye drop which i had to use 6 times per day for 8 weeks.None of these treatments have done anything to alleviate the living hell i now find myself in.The situation has now deteriorated to the point where i have to wear dark shades at all times.I also have to wear a special pair of contacts called scleral lenses which i traveled to (b)(6) to have custom made.The public is led to believe that refractive eye surgery is safe.It is not.It severs the corneal nerves which never regenerate fully after they are cut.These nerves control the tear response, which is also connected to the lipid component of the tear film.Once this delicate system is destroyed a person's once healthy cornea is then compromised for life.In addition there is now a lasik scarred cornea.These two situations unnecessarily compromise a person's once perfectly healthy cornea for the rest of their life.Let me preface this by saying that i am not actively suicidal.Every single aspect of my life has been utterly devastated due to my current lasik induced health and mental health issues.I have attempted suicide multiple times and was voluntarily hospitalized in a mental health clinic due to this condition i am now in.I met a refractive surgery survivor named (b)(6) online.She suffered from the same problems i have been going through for the past 34+ months.She committed suicide (b)(6) 2019.She could no longer handle the torment of this condition.There is no peace or relief from this.Normally in life if a person has an issue they can just go home and sleep it off.With this there is no way to escape.You cannot escape your eyes.Every day for the past 34+ months have felt like low crawling through 1000 yards of razor wire.This has completely destroyed my will to live as i see no way out of this.I now have to watch as my eyes continue to break down and deteriorate for the next possibly 50 years.I am scared i eventually will not be able to work and will have to spend the rest of my life laying on the couch with my eyes closed which has happened to numerous eye surgery victims i have met online.I have no appetite.My sleep has been disrupted.I cannot concentrate like i need to.My finances have been severely damaged.My social life is now non-existent.My work life has suffered.My peace of mind is long gone.I used to exercise daily and now have not exercised for over 3 years.My mind rejects all of my hobbies i once enjoyed.All of my family relationships are under extreme pressure.I am now on the verge of total collapse.Fda safety report id# (b)(4).
 
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Brand Name
LASIK
Type of Device
EXCIMER LASER SYSTEM
MDR Report Key10691704
MDR Text Key211739798
Report NumberMW5097272
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/14/2020
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? Yes
Device Operator Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
CEQUA SCLERAL CONTACT LENS ; DRY EYE GLASSES; FISH OIL; KRILL OIL ; VITAMIN A; VITAMIN D
Patient Outcome(s) Disability;
Patient Age25 YR
Patient Weight75
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