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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX VISX STAR EXCIMER LASER VISX LASER

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VISX VISX STAR EXCIMER LASER VISX LASER Back to Search Results
Event Date 10/23/1997
Event Type  Injury  
Event Description

Lasik eye surgery has destroyed my quality of life, and has drastically and irrevocably slashed the time that i have to "live" life. My personal, professional, financial, recreational, social, parental, and every other aspect of life that has been decimated by lasik. The motivation necessary to live this barren existence is that i do not destroy my children's lives by killing myself. I cannot tell my children from their friends in my own home from more than 4 feet away - last year it was 13 feet-; extremely limited driving only during daylight, and non during night; unable to walk alone at night various visual disturbances above and beyond extremely poor visual acuity that has regressed since lasik, such as: starbursts; halos; ghosting, loss of contrast sensitivity resulting in poor depth perception - i trip on steps because i cannot tell whether they are steps of flat; unable to read newspapers, instructions, menus, ingredients, dosing instructions on medications, bed time stories, etc. - thank god for the (b)(4). -; ptsd post traumatic stress disorder- and resulting anxiety and depression; hospitalizations for suicidal ideation; financial loss and injustice of a medical malpractice lawsuit that deserves its own documentary detailing the inadequacy of the justice system, and the need for improved laws regarding informed consent, statuses of limitations to file and trial the case, orders of protection, what constitutes evidence and what is mere deception, serious criminal charges for perjury, what constitutes double jeopardy, need for objective expert witnesses, and orders of protection for plaintiffs, and their attorneys and expert witnesses; career destroyed. Went from making (b)(6) a year to disability; unable to protect and provide for my family; unable to enjoy television; unable to play most sports due to poor vision and the astronomical possibility of needing cornea transplants if i get hit in the eye with a ball, a finger, etc; severe pain from corneal neuropathy from lasik. This pain is so severe that i said to my wife, in front of my (b)(6) daughter (b)(6), that "may be i should just have my eyes removed, and learn to live as a blind person", at which time (b)(6) became hysterical crying, because she knew that i wasn't kidding. This eye pain i can only describe as feeling like someone jammed an ice pick into my eye, and the accompanying "suicide headache" is equally severe and appropriately named. There really is hardly an aspect of life that has not been scorched due to lasik. We have no idea how precious our eyes are until they are destroyed. I was told by one psychologist that he considered my ptsd situation to be "worse than that of someone who was buried alive who survived", because the visual reminders of the trauma that continue to be trauma are there before my eyes every waking moment of my life. Measurable physical damage to my eyes from lasik: corneal ectasia -also called "kerectasia" or "keratectasia"- - lasik induced thinning and weakening of the cornea, causing the cornea bulge forward due to the intraocular pressure pressing out on the thinned out cornea. This can eventually burst the cornea, necessitating corneal transplants; decentered ablations - causes visual distortions that you cannot even imagine unless you have studied optics; ablation zones that are too small relative to the pupil as it dilates in low light situations resulting in the same visual distortions just mentioned; higher order aberrations - i imperfections in the cornea -peaks and valleys rather than a smooth corneal surface- that prevent light from focusing directly on the retina causing visual disturbances like starbursts, halos, optical illusions, etc. ; decreased contrast sensitivity- impairs depth perception; corneal neuropathy -causes depilating pain in eye and head. Neurologists sometimes refer to these headaches as "suicide headaches" because the severity is so great the suffers often contemplate suicide to stop the pain. Corneal scarring; irregular corneal distortion; irregular astigmatism; lasik flap which never heals - allows the stromal layer of the cornea to be exposed to outside elements which nature had never intended; additionally, over the years my visual acuity has regressed to almost it's pre-lasik point of 20/80 and 20/200 - lasik doesn't even permanently eliminate the need for glasses or contact lenses. This regression takes place over varying amounts of time for different pts, and has not been studied because the lasik industry knows exactly what it will find. The unethical, malignant, narcissist lasik surgeons, staff at (b)(6), laser manufactures, and the rest of the lasik industry that shamelessly peddle and perform this barbaric and always - 100% of the time- detrimental procedure should have their licenses revoked, their businesses shut down, and commercial, civil, and criminal charges should be brought against them. Class action lawsuits should be filed as well. What is the fda doing about this issue that they have known about for a decade? why have they not responded to (b)(6) formal petition calling for an end to lasik? may the laws of karma be enforced on all knowingly involved. Lasik injured pts families are significantly affected. I'm just too tired to write about this now. They should have the right to sue the lasik industry for all that they lost. Some close family members may also experience ptsd due to the upheaval that ensures from lasik injury. This document may not contain all of my complaints regarding lasik.

 
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Brand NameVISX STAR EXCIMER LASER
Type of DeviceVISX LASER
Manufacturer (Section F)
VISX
Manufacturer (Section D)
VISX
Device Event Key2562284
MDR Report Key2532690
Event Key2429443
Report NumberMW5024983
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/07/2012
2 DeviceS WERE Involved in the Event:1 2 
1 Patient Was Involved in the Event
Date FDA Received04/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 04/07/2012 Patient Sequence Number: 1
Treatment
PILOCARPINE
MICROKERATOME
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