The FDA's medical device reports (MDRs) are intended to function as an "early warning system" that can alert the FDA to adverse events that may not have been discovered or investigated during the clinical trials process. The MDRs for refractive surgery are saturated with depression and suicidality, including some reports of actual suicide. Yet, the FDA refuses to recognize the connection between refractive surgery results and suicidality. Perhaps the FDA "cannot" recognize this association because it would support corruption in the clinical trials, as alleged by Dr. Morris Waxler, the FDA's chief research scientist on LASIK, at his website HelpStopLasik.com. Note as you read these that it is "side-effects" like dry eye and visual aberrations that are prominent in causing depression and suicidal ideation, not the adverse events recognized in the clinical trials. Why is the FDA not publicizing this connection?

Below are some of the Medical Device Reports that mention depression and suicidality. The first is the report that I made following my son Max's suicide due to PRK.

MDR for my son, Max Cronin: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036134

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).

From http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=5113126

Caller advised he had lasik surgery at (b)(6) on (b)(6) 2011. Surgeon mentioned potential adverse effects which was supposed to be temporary. "my life has been a complete nightmare after the surgery". Caller fell into a deep depression with suicidal thoughts and is currently on medication for depression and also seeing a therapist. Caller is still experiencing night vision problems which include blurred vision, glare, halos, diplopia in the left eye and distorted vision in the right eye (sees four different images when looking at one image) and dry eyes. Caller advised lasik eye surgery is very dangerous and was never warned about the psychological effect the surgery will have on him.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4024257

I had lasik done 6 months ago. The outcome has changed my life forever. I now have terrible night vision, which now includes huge starburst and glare. My eyes really aren't dry, so i guess i dodged that bullet. The worst thing about it is that fixing my night vision problems would now require a hard rigid lenses designed custom made for my eyes, which may not even fix my problems. Before i had perfect vision with contact lenses. What a terrible mistake i have made. I am only (b)(6) and now for the rest of my life i have to right this devastating condition. Why is lasik even legal, why was i not told directly by the doctors that my large pupil would cause poor night vision. I would give every dime to my name to get my old crappy eyes back that were fixed perfectly with contact lenses. I have considered suicide on several occasions. I have never ever been suicidal my entire life. I am now on antidepressants which i know is the only reason i am here today explaining my struggle. I can no longer enjoy my night outs with my friends, i can't go anywhere at night without a horrible headache from trying to see. I pray and pray that they will find a way to cure this condition. Please shut down lasik.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3972765

I had lasik on (b)(6) at laser vision (b)(6), the doctor was (b)(6). I was (b)(6). On (b)(6 ) 2014 i have been diagnosed with severe dry eye due to the surgery. I am on depression with suicidal thoughts. (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=3518657

Patient called to report adverse events after receiving lasik eye surgery with an allegro wavelength laser on (b)(6) 2013, in both eyes. Patient stated prior to the procedure, he had no issues with his eyes. He said around (b)(6) 2013, after the procedure, he started to have extreme, severe dry eye issues that were extremely painful. He also explained that he can't keep his eyes open and that his eyes feel like they are being pulled forward. He is extremely upset with his current condition and said he hasn't been able to work since (b)(6) 2013. Patient said he has seen 3 ophthalmologists and spent $(b)(4) trying to correct the adverse reactions. He said it's difficult for him to function. Patient explained he was told that his condition is chronic and he is worried about his future, he feels disabled. He said he has contemplated suicide and is talking to a therapist. He said his pain is so bad that everyday he lives in torment, and that he may not be around very much longer to see if his condition ever improves. The patient was transferred to local (b)(4) crisis prevention hotline.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2614700

I have chronic aqueous deficient dry eye aka neurotrophic keratopathy or refractory dry eye. My eyes do not tear when they are dry or come into contact with irritants and allergens. This is an extremely painful and degenerative condition though i don't think i will be around to see exactly how bad it gets because i intend to end my life soon. My doctor claims that it is not possible for this to be a result of lasik. However, when pressed he said that up to 40% of lasik patients have some degree of residual dry eye. He is full of contradictions. It depends what you're asking him and in what context. The answer changes regularly. It took me 6 years to find a doctor that finally told me that this condition is in fact due to lasik surgery. This is due to a concerted effort by ophthalmologists to cover up for each other. Even though they knew better they sent me on a 6 year quest to find out what i should have been told before the surgery. Lasik causes extreme dry eyes in many people, especially people like me with high risk factors.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2019933

I had lasik surgery on (b)(6) 2007. The surgery was performed within 4 hrs of my initial visit. I have not had clear vision since the day of surgery. My problems include dry eyes, halos, starbursts, no contrast ability, lack of peripheal vision, extreme sensitivity to light, and now bilateral cataracts. I was told at every visit that these complications would resolve over time. Of anything, my symptoms have become worse. I faced an unk amount of surgeries to remove the cataracts and i am concerned about the instability of my corneas, which have been damaged and will at some point require corneal transplantation. At the time of my surgery, i was earning in excess of (b)(6) per yr. Due to my declining visual ability and debilitating depression, i am on (b)(6), wherein i receive a monthly stipend of (b)(6). I have attempted suicide more than 5 times since my lasik.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2095463

I had two lasik eye surgeries in 1998, using a visx star laser. The surgery was done to correct myopia and astigmatism. The surgery was performed twice on each eye; once in (b)(6) and once in (b)(6). I knew going in that i would need two surgeries because of the extent of my myopia (approximately -12. 50 and -13. 50). Initially, my vision was good following the second surgery. However, my vision has deteriorated in subsequent years and continues to get worse. I have starbursts, halos, glare, and ghost images at night. Neither contacts nor glasses have been able to help these problems. I have recently begun seeing double images, starbursts, and glare sometimes during the day. I don't know what the future holds for my eyes, but i am worried that the deterioration will continue. There seems to be no solution. No one seems to understand the impact that this loss of vision has had on my life. My eye doctor talks as if i should be grateful because using the eye chart i can see around -. 05 in both eyes with a slight astigmatism. However, the crazy images i see have led me to be depressed to the point of considering suicide at times. I have not received a good explanation for why my vision is deteriorating. Three parties were involved in these events: my o. D. , the surgeon, and the center where the surgery was performed. All of my follow up has been with my o. D. Who recommended the surgery and set everything up. I believe they all had my best interest at heart. I report this event not to point fingers at anyone, but to warn others that this surgery has serious risks. I do not want anyone else to go through what i am going through every day, probably for the rest of my life. Dates of use: (b)(6) 1998.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1905783

Had lasik eye surgery on (b)(6), 2010. Now cannot see to do any of my daily tasks. Near and mid-vision are gone. I only see far away. Was only told i would need readers for the computer. Local doctor can't believe how farsighted they made me. I am preparing to commit suicide after i get me affairs in order for my children. Only those who have gone through this nightmare understand the guilt and shame. You spend thousands of dollars and have no recourse whatsoever when the outcome is bad. It is a great scam for the lasik centers. Where on earth could you buy a product and then not have any recourse if it does not work??? please put a stop to this before others die or ruin their lives!!! please listen to us!!!.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1284908

I had lasik surgery to my left eye and prk to the right eye in 2007 at the vision center,. I had planned to have the surgery done in 2006, but decided to pass due to my family visiting us and travel commitments. Before making the final commitment to have the eye surgery, i went through a number of tests at the vision center to ensure that i was a good candidate for the surgery. Dr and several of the other examining doctors assured me that i was good candidate for lasik surgery. Dr indicated that having lasik would reduce the time for recovery and be less painful overall. I talked myself into having the surgery and decided to go for it in the same month. I was all set to have the procedure done the morning of the same month when another dr, the surgeon performing the eye surgery, suggested to have the tests redone since it been six months from the last examination. It made sense, so after the completed examination, dr(second) informed me the left was fine for lasik surgery but he felt that i should reconsider to have prk surgery on the right eye. His reasoning was that my prescription and astigmatism were stronger on the right eye and felt that having lasik would not get the results i wanted. Secondly, he said that if later down the road i wanted to have nay corrections made, they would not be able to perform additional surgeries on the right eye because the cornea was not thick enough. This all occurred 10 minutes before the surgery was to take place. He did state it would take much longer to heal, up to 6 months - 3 months for the lasik-for the vision to achieve the desired state. At the time, i did not think it sounded like too long to wait. I spent 48 years of my life with glasses-six months was not a long time. I should have walked away and re-evaluated the length of time. I had spoken to other people who had the surgery, and they didn't have any dryness at all or if they did it only lasted a couple of weeks. My eyes were in constant pain following the surgery and lasted for months. The nerve endings were supposed to heal within 2-3 weeks, but in some cases they never return to their normal or previous state. This is something that i was not told before having the surgery. If they would have told me this i would have passed on the surgery. The bottom line is that i suffered daily with pain, dryness, and burning for almost 9 months. I experienced periods of deep anxiety, depression and the inability to sleep that began about 30 days after the initial surgery. The resulting surgery has left me with extreme night vision problems including halos, star-bright and double vision. I'm afraid to drive at night. Following the surgery, i suffered with high anxiety and depression for over 8 months, which resulted in having to take many strong medications for anxiety and depression, including 3 days in a mental facility. I still take the anti-depressant medication and suffer daily with vision problems that affect my ability to read. My job requires that i work on the computer all day. The resultant surgery almost cost me my job due to lost work days and the inability to travel. For the first 6 months following the surgery, i experienced extreme difficulty sleeping and had to take strong addictive medications, such as lorazepam - anxiety- and ambien cr sleep deprivation. It has been 21 months since the surgery and my vision is still poor in the both eyes. Additionally, more in the right eye. I meet with dr wright at the vision center in 2008. After several tests, dr(first) indicated the right eye prk surgery could not be corrected. Additional surgery to the right eye may not improve the astigmatism or the halos and star-bright conditions. Dr(first) configured a pair of eye glasses after his examination hoping that it would improve vision in the right eye, but proved useless. The story does not have a pretty ending. Prior to the surgery, my eyes were correctable with eye glasses. After surgery both of eyes maintain the astigmatism and include additional defects such as halos, star-bright, and double vision. Not to mention the visual daily strain on my eyes because of the astigmatism. Unfortunately, i was one of the few that experienced sever problems as a result of the eye surgery. The fact that no support structure was in place for patients who experienced that trauma as i did made the situation even worse. I tried to get help from lasik plus, but all they could say to me was , we are sorry. My family went through a very painful period after my surgery. I was fortunate to have a wife who prayed and comforted me through this period but after 6-7 moths of being up all night and having to stay home with me during some of the rough days, it took its toll on her as well. If it were not for my strong relationship with jesus christ and many christian brothers and sisters praying for me daily, would have most likely taken my life. Dose or amount: no medication.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036134

In 2002, i underwent bilateral lasik surgery to correct nearsightedness. The result in terms of vision were successful, but i was left with extremely dry and debilitating dry eye. Due to the dryness and extreme discomfort, i complain often of eye strain in my forehead and brows. This is extremely uncomfortable and is difficult to control. Since my surgery five plus years ago, i have continuously experienced dryness and burning. The immediate effect of my lasik and dry eye was severe depression that endured for three years post-surgery. My depression was further debilitating, resulting in my inability to care for my very young family. My mental state required me to make several treatment attempts including medication and therapy. I had no prior history of depression. I found the onset of tremendous physical pain to be shockingly hard on my psyche. I have had to learn to manage my dry eye, but cannot report any true good, comfortable "eye" days since my days prior to surgery. In order to maintain any comfort at all, i must wear windless eyewear outside at all times and sometimes inside. I use eye drops all day and often at night. I use warm compresses on my eyes twice daily to maximize oil output thus improving my tear film. I also partake in oral omega 3-6-9 supplements in a further effort to improve my tear film. A humidifier at my bedside year around also improves my nighttime dryness. Suffice it to say my experience with lasik was a disaster. Clearly i was not a good candidate for the surgery despite the fact that my vision was easily correctable. It is unfair for the fda and the refractive surgery "industry" to continue this dangerous surgery on patients who do not meet a strict criteria. Contact lens intolerance should contraindicated in this surgery.