MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138); Anxiety (2328); Depression (2361)

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).

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 5434049
• MDR Text Key: 38287677
• Report Number: MW5060153
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 27 YR
• Patient Weight: 82