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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Date 01/14/2016
Event Type  Death  
Event Description

My son, (b)(6), committed suicide (b)(6) 2016 by a self-inflicted gunshot wound in (b)(6). He wrote suicide notes stating he killed himself because (b)(6) ruined his eyes from a prk procedure (a type of lasik eye procedure) and thus ruined his life. My son, (b)(6), was (b)(6). He was pursuing his college degree at (b)(6). His career was in petroleum engineering. He had had a problem with depression in his early teens, but had been stable without problems until after his deployment to fight in (b)(6). (b)(6) had an uncomplicated lasik surgery through (b)(6) approximately 5 years ago, in 2010, with eventual deterioration of his vision in (b)(6) 2015. He had a prk procedure (b)(6) 2015, by dr. (b)(6). He had a minimal history and physical prior to the procedure. There was no information on my son's diagnosis of ptsd, anxiety, learning disability, or depression. There was no identification of the medications he was taking. Post procedure, he experienced persistent eye pain, dry eyes, and eventually loss of his eyesight to 100/20. His loss of his vision in (b)(6) 2015, resulting in him not being able to visualize adequately to continue his classes and he was unable to obtain employment for his loss of vision. He repetitively saw dr. (b)(6) who continued "conservative management", despite my son deteriorating psychologically. His post operative care included a physician antagonistic to my son, with no referral to another physician, to blaming the patient for the complication, and ultimately the patient feeling hopeless and suicidal. This eye laser complication placed my son in economic distress and immediately resulted in deterioration psychologically. He wrote suicide letters stating he was killing himself due to his ruined eyes by dr. (b)(6). I am a board certified ob/gyn, which includes board certification as a surgeon. I am horrified at the lasik false promotion of a "safe procedure", when, in reality, lives have been destroyed with medical physicians placing monetary gains over the health care of patients. After my horrific loss of my son from his loss of vision from this prk, lasik procedure of his eyes, i have been even more horrified of the complications and suicides related to loss of vision from elected lasik procedures, the devastations to lives that have incurred complications, the common complications not declared to patients, and the scant medical awareness of the patients by the physicians prior to these procedures. (b)(6).

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key5434049
Report NumberMW5060153
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Report Date 02/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2016
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: 02/09/2016 Patient Sequence Number: 1
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