Neurologist submits LASIK complaint to FDA

Date received by FDA: August 2, 2010

I am writing to add to the growing reports of long term adverse effects post LASIK eye surgery. In 2002, I had LASIK with the company Boots in [redacted]. I am a neurologist and should probably known better but believed the consent process would be similar to that of operations carried out in the [redacted]. Whilst I accepted a small risk of visual aberration -halos etc- there was never at any time mention of a risk of permanent dry eyes. I suffered severe painful dry eye requiring punctal occlusion immediately post op which lasted for around 3 months. I had no preceding history of dry eye and no risk factors -male & otherwise well on no medications-. Dry eye symptoms then improved for around 18 months before I started having bouts of severe eye pain lasting a few days or a week or two. However, I have now had severe dry eye pain continuously for a year which has been devastating. I am in the medical profession and hence seen numerous ophthalmologists and tried all the usual treatments without any success -plugs/drops/compresses/omega-3/steroid drops etc-. The symptoms have ruined my quality of life at a time when I should be enjoying a new family and successful career. Instead I have become clinically depressed requiring high doses of anti-depressants -with no prior history of any depression- due to chronic -eye- pain. I have been near suicidal with the usual issues -guilt, anger, pain, despair- and cannot at present see how I can continue to function at work for very much longer. Lasik has converted a vigorous, academically and professionally successful physician and young father into a depressed and introverted pt who fears for the future and a life of chronic eye pain. Whilst my individual case is of itself anecdotal that is the real scandal here. There appears still no robust data on the incidence of permanent life altering adverse events post LASIK and it is clearly not in the interest of the providers of this surgery to collect this data or make it explicit. However, it would be a relatively simple audit to conduct given the huge numbers of people who have under gone this surgery - a random mailing of only a fraction of a percent of those having had surgery over the last 10 yrs would provide crucial data on the true incidence of permanent adverse events on which people could then make some form of an informed consent. The second issue is the importance of requiring consent to highlight the severity of potential adverse events, even if these are rare. I for one -and I suspect most/many others- would not have had the procedure if I had known there was any chance of a chronic pain condition. Young adults in the prime of their life are having elective surgery with the risk of potentially life altering adverse events for which there is little therapy. Post LASIK dry eye is a completely different ball park from age related aqueous deficiency dry eye -both in terms of associated pain and relative resistance to the usual therapies despite what ophthalmologists involved with LASIK continue to suggest. The fact that those consenting pts to LASIK are financially motivated makes it even more important that non-biased audit and regulation of this surgery is carried out. Sadly is suspect given another 5-10 yrs, we will have a generation of refractive surgery pts whose life has been de-railed/destroyed by LASIK complications, a generation of doctors and companies that have profited from the unchecked/unregulated proliferation of this surgery and a group of regulators who will look back on the fiasco perhaps to consider whether the pts best interests have really been served in the way this surgery has been introduced and allowed to escalate unchecked and unregulated. For myself, I do not know what the future holds but a single uninformed decision at the age (b)(6) has wrecked my quality of life and I urge you to move to collect data on longterm risks without further delay and to regulate/standardise the consent process of this procedure in light of this data. I find it hard to believe this was not a requirement of the original approval process.

Link to report on FDA website