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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXCIMER LASER

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EXCIMER LASER Back to Search Results
Event Date 10/14/2014
Event Type  Injury  
Event Description

Microkeratome custom lasik in (b)(6) 2014. No egregious negligence intra-op (certain negligence preop: missed diagnosis of rosacea). Informed consent practices unethical, bilateral treatment (both eyes) prevents ability to provide true informed consent. Lasik, microkeratomes and excimer lasers are flawed to begin with but at the bare minimum need to be labelled as the high risk devices for which they are. On to the adverse events. Following lasik, i experience unremitting dry eyes and pain in general. So much that i cannot go about my daily tasks because my eyes are always hurting and look the part too (bloodshot, glazed). My night-vision (low light conditions, driving) has been severely hindered and compromised. The corneal flap created in lasik never heals and now that is another adverse event report just waiting to happen. My vision is now filled with floaters as a result of the invasiveness of the procedure and i am looking at a vitrectomy and cataract surgery in the future, not to mention an overall weakened eye in terms of its health and biomechanical strength. Be these things as they may, just directly inform the public of them. I can honestly say that i was barely aware of the frequency and severity of the complications of lasik. This lack of info and misinformation is purposely crafted by these clinics who care not one ounce for pts whose eyes and lives they destroy. The fda and it's lax regulations are ineffective and insufficient in combating the false advertising and public perception of laser correction. I urge you, by all that is good in the world, from every fibre of my being and of the others injured by lasik, to issue a public health advisory and/or black box warning like so many before we have asked of you. I had to leave my job because my eyes hurt all the time and i can no longer look at a computer screen while maintaining customer service and my other job responsibilities ((b)(6)). My social life has completely eroded and my personal prospects have been lost. If i did not have the support of my family, there would be nothing to prevent me from falling into a deeper depression than i already am. Suicidal ideation is something that i am now all too familiar with. My life has completely deteriorated because my eyes have been severely damaged by a unnecessary and very much corrupt procedure and industry. And my life was good. I was happy. I did not ask for this, nor was i even aware that it could actually happen. Lasik has been the worst decision of my life and i regret it every day and surely will continue to regret until the day i die. I am (b)(6) as of this writing and by the way, the clinic considers me a success because i can roughly achieve 20/20 acuity, other complications be damned. I was 20/20 with my glasses of course so benefit has hardly been worth the risk. The fda held a lasik panel in april 2008 where numerous people, pts and professionals alike, told you everything you needed to know about lasik. Seven years later and nothing has changed. If you were to host a similar forum today, the testimonies would be the same, only in greater number and in greater detail. You conducted a quality of life survey with results published in october 2014 where "disabling symptoms were found in a significant numbers of pts". How many eyes and lives must be destroyed before you do what is right and alert the public and black box this product? these ophthalmologists are not ethical. They have long departed the path of medicine and healing in search of financial gain and ego. And this is the root of the problem. Profit over pt welfare via indifferent laser surgeons. You could be an ideal candidate, a poor candidate, it makes no difference. They want you under the laser, out the other side so they get rich and an innocent person is needlessly compromised. The stakes are too high. Our precious eyes, please do something!.

 
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Brand NameEXCIMER LASER
Type of DeviceEXCIMER LASER
MDR Report Key5074969
Report NumberMW5056109
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2015
Is This An Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/08/2015 Patient Sequence Number: 1
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