- [Person] Don't follow the light.

Just look straight past it.

The clouds are coming in.

It's going to go all fuzzy.

You feel anything?

Certainly no pain, right?

Okay, close the eye.

(tense music) - What's a frog say?

(baby shouting) What's a frog say?

- Ribbit.

- Everything I saw was so distorted.

I could hardly recognize my face or the faces of my family members.

When I realized that things weren't going to get better, I've never felt so much pain and regret in my life.

I've wanted to become a filmmaker ever since I was a kid.

We had a video camera at home and me and my sister would make our own videos.

I first went to Nashville and then I found myself out in LA where I was able to take part in the film business for a long time.

And when I moved back to Minnesota, I eventually started working at a PBS station where I became the executive producer of a show called "Postcards."

"Postcards" has given me the opportunity to travel all over the place, cover every corner of our state and work with creative people all the time.

And it's been really exciting to build my whole career around the visual arts.

So when I thought about filmmaking and being able to see well, I thought at the time that getting LASIK would help me see better and then somehow improve my career and improve my ability to make films and see...

I drove to my pre-op appointment with my husband and they told me that I had nothing to worry about.

The surgery was 99.9% effective.

Then the actual surgeon came into my appointment and he said, I heard that you're a filmmaker and you're worried about getting the surgery and losing your eyesight.

And he said, you have nothing to worry about.

I am the best surgeon in the country.

We had two doctors and a surgeon tell us that I was a perfect candidate and that everything was 100% safe.

The complications I have from LASIK are, I have about negative 0.75 in both eyes.

So I still need glasses to be able to get around and to drive.

I have visual aberrations that are called higher order aberrations: halos, starbursts.

I have a waviness- A sensation of flashing lights- Because my cornea- Goes on all the time.

My eyes are so painfully dry.

Sort of like I have a bad migraine but it just never goes away.

I have nerve damage as well which causes me quite a bit of pain.

It feels like there's glass in my eyes at all times, especially at night.

Even just the slightest air moving through the room or a slight breeze outside is completely disruptive.

I have to wear goggles when I go outside in the wind.

I have to wear goggles when I sleep at night.

I have to put in upwards of 20 eye drops a day to keep my eyes comfortable.

Some of them are made from placenta.

Some of them are made from my own blood.

So I have to go into the city and get my blood drawn every three months to make these eye drops.

I spent $6,000 on LASIK and since LASIK I've spent probably another $3,000 in the first four months post LASIK just on treatments for my eyes.

- [Narrator] Life doesn't have to be limited.

You know, life doesn't have to be limited.

- [Narrator] No glasses.

No contacts.

No blades.

No pain.

- [Narrator] Quick 15 minute corrective procedures.

We stand behind our results with our TLC lifetime commitment.

- LASIK is a multi-billion dollar industry and it relies on the fact that it can make quick sales on a grandiose idea like waking up tomorrow and not needing your glasses anymore.

If you have complications, all the better, they'll make money off of you that way too, 'cause they have all the treatments.

Every LASIK center has a dry eye clinic attached to it.

- They don't want you to know the science behind it, because that makes their job a lot more difficult.

So they gloss it over.

They said, you know, you might have some dry eyes but they'll go away.

I think the reason that you don't hear about these stories more is because the surgeons try to convince people the problems they are having are unrelated to LASIK and they try to shame patients into thinking it's a mistake that the patient made and not from the surgery.

(soft, tense music) I doubted his words.

- [Doctor] That's certainly not anything related to LASIK.

- So I went to Boston for an expert opinion.

- I am an ophthalmologist.

I have been an ophthalmologist for 40 years.

I was one of the first people in the world to hear about LASIK because it was invented by a colleague of mine, Dr. Stephen Trokel.

We worked together at the Harkness Eye Institute of Columbia Presbyterian Hospital and one day in the early 1980s, he came dashing into my room in the clinic and he shoved a paper in my hand.

And the paper had a picture of a cornea and it had an exact rectangle sliced in it.

And he said the rectangle had been cut by an excimer laser.

He was planning to use it to shave and reshape the cornea to change the focus of the eye.

The cornea is living tissue and it has all these nerves running through it.

And if you reshaped it, you would be thinning it, you would be causing unbearable pain and there'd be scarring.

And I thought, this is ridiculous, no one will ever be interested in this.

- [Jimmy] Can you see me, by the way?

- Uh, yeah.

- Okay, good.

Because I just wanted to, didn't you just get LASIK surgery?

- I did.

How do you know that?

- Two days ago, I woke up and I couldn't see out of my right eye.

So I went to the doctor and he said there's significant damage to the eye.

It dried up while I was sleeping and then when I opened it, it ripped that layer off of my, from LASIK eye surgery.

- I'm a bit blind in the eye.

- You've always had bad sight in one eye?

- No, what happened is I got my eyes lasered like when I wasn't meant to like 15 years ago and then that one in a million chance, that one reversed.

- I've been putting something off that I should have done two years ago or so announcing, I have to wear glasses.

(audience laughing) I... (audience cheering) Cheering like I just came out as gay.

What the f***?

So brave, Bill, to wear glasses.

It's not brave.

I've had three LASIK surgeries.

I can't f****** see anymore.

- Do you feel like, - If people knew how LASIK is performed, nobody would have that procedure.

You take a normal, healthy eye that sees beautifully, feels great, and you crush it, you flatten it in a vice, so the pressure inside shoots up to three times normal.

And this high pressure and this squashing damages the retina, the part of the eye that actually sees.

The next thing they do is to cut a slice off the cornea.

The reason they flatten the eye is so they can cut a flat slice.

And they take off a flap, they lay it aside, and then they take this naked inner part of the cornea, and they shave it using an excimer laser.

That's a cold laser.

It doesn't burn tissue.

And then they put the flap back on.

The flap never heals normally.

It's on the eye, but it's on no more strongly than a contact lens.

It's only got a two to three percent of its original strength.

So if you rub your eyes or if you're hit by a wave or you play contact sports, the flap can get dislocated, which means you immediately lose the sight, you've got to find that flap and get it put back on, and then it's much more likely to dislocate again.

- All I wanna see is more honesty around the issue.

I just want surgeons to be honest with the patients about what they're doing to their corneas, which is taking a healthy cornea and turning it into an unhealthy cornea.

This is exactly the opposite of what I thought I was doing.

I thought because I had bad eyes and then I would have good eyes afterwards that somehow I was improving the health of my eye...

But I didn't realize that I was putting my eyes at risk to have all sorts of complications that would last a lifetime.

(siren wailing) - At least 50% of them will have a gritty feeling like there's sand in the eyes.

At least 60% of them will have fluctuating vision.

They'll have vision that changes from light to dark and from morning to afternoon.

Some LASIK patients have many different eyeglasses.

One out of every five people will have changes.

They will either go right back to being nearsighted, just what they were before except with pain and distorted vision and glare and halos at night, or some people go in the opposite direction, get more and more and more and more farsighted.

The cornea isn't a piece of plastic.

It's living tissue with nerves running through it.

Also, the cornea grows throughout life.

So, of course, it's gonna start to remodel and change.

- I feel there's a certain amount of responsibility to say the least.

- [Reporter] Dr. Morris Waxler was on the Food and Drug Administration team that approved LASIK in 1999.

- I am disgusted that I was a part of that approval process.

- [Reporter] He says the government rushed to approve the procedures because the surgeries were already being done illegally and needed to be regulated.

- That man's an FDA advisor who told the government to approve LASIK surgery.

That was back in the 1990s.

He tells the eye team now that that should have never happened.

This as more and more patients are having the procedure and a number of them are seeing problems rather than seeing better.

- I trusted the surgeons.

They were very affable, all very famous, well-spoken.

Fundamentally, I had a lot of trust that they would not harm people.

And it turned out to be a totally misplaced trust.

It was astonishing to me.

It was, how many eyes I could get through in a minute, just as blunt as that.

For 60% or so of the patients, there's an immediate wow effect because essentially when they cut the cornea, they're anesthetizing the cornea.

Because they're cutting the nerves that serve pain sensitivity.

So for a while, most patients don't feel much problem.

But when the nerves start to go back, then the pain starts to come back.

They have to measure the thickness of your cornea in order to decide how much tissue to remove.

But that measurement is actually fraught with a lot of error.

It's pretty good.

But pretty good is, you know, what do you mean pretty good?

You're talking about, you're talking about microns of tissue.

So a little error here is a big problem.

- It's a big assumption they've made since they started this whole business of refractive surgery.

They know from autopsy material what the thickness should be.

But they cannot know in any particular eye whether that amount of weakness is too much weakness.

There are too many individual variabilities and measurement error that occurs to be sure.

So the answer to your question is they don't know.

- [Dana] By the way, I'm in Florida now.

I'm meeting Dr. Edward Boshniok, an expert on restoring the vision of LASIK patients like me.

- Is that height okay?

- Yep.

- Okay.

Good.

- What's that?

Can we put more force in it?

- Yeah.

- You can sit back.

Other complications or higher order aberrations where patients will see double vision, starburst, halos, glare, reduced contrast sensitivity.

Any or all of those.

Patient by patient and eye by eye.

Some patients may be happy with one eye, the other eye is a disaster.

- Right here, you're looking at all the different kinds of aberrations you can get and we're measuring them.

And then these blue bars are showing how much of that abberration you're affected by.

Anything that goes above or below the green line is significant.

You're definitely noticing that.

But these ones are definitely really large.

I've never seen it that large in anyone we've done this on.

And then so this is your right eye and this is your left eye.

So you have some pretty significant aberrations that are affecting you.

- Many patients who have had complications from LASIK surgery, their corneas are very distorted and irregular, making it impossible to wear regular contact lenses.

Eyeglasses can't correct these situations.

The only technology that's going to correct a patient experiencing visual distortions like halos, glare, starburst, double vision, it's gonna be a well-designed and fit scleral lens, that's just it.

(soft, tense music) I just don't believe in this procedure.

I think it's a harmful procedure and I don't want that on my conscience, someone getting hurt.

I have seen thousands of patients like this.

I have never seen a second surgery undo the damage caused by the first LASIK surgery.

I have seen patients who've had significant problems develop 10, 12 years after the LASIK was done.

I'm Dr. Edward Boshniok.

I'm an optometrist in Miami, Florida, in the private practice for over 37 years.

Over the years, I've devoted the major portion of my practice to the non-surgical treatment of patients who have lost quality vision due to ocular trauma, disease, and refractive eye surgery, including LASIK.

I think LASIK is a clear and present danger to the welfare of the American public.

And I said that 13 years ago.

Some of the patients I have seen have lost their jobs and families as a result of their vision loss.

Two of my patients have attempted suicide on multiple occasions.

Three of my patients have spoken to me about suicidal thoughts.

The complications I have seen include severely distorted corneas resulting in loss of best corrected visual acuity... (soft music) - [Dana] I went back to Boston for another second opinion.

(soft music) - People think about the cornea as a small piece of transparent collagen, but the cornea is actually a very complex organ.

It not only has a lot of collagen and it's transparent, but it has a lot of different cell populations in it that contribute to various functions.

Like any other tissue in the body, it's innervated by nerves that kind of sense what's going on in the tissue.

So it's very sensitive.

- The cornea has more nerve endings than any other place in the entire body.

So if you go into a cornea and cut all those nerves, that's a terrible thing to do.

The nerves are never going to grow back normally.

They're going to start firing constantly.

They will give you this gritty feeling.

The LASIK surgeons call it dry eye.

It's corneal neuropathic pain.

It's pain in the cornea caused by the corneal nerves being cut.

- And they can't know exactly where those nerves are running.

There's no way to know that.

They try to avoid, they come in on a particular pattern and then they disperse.

But there's no way to know in advance how that dispersion is occurring in your particular eye or in a particular customer's eye.

- I think corneal neuralgia, like any other pain, can result in disability.

I think any pain, once it gets above a certain threshold, can disable somebody.

Basically anything that results in nerve damage can cause corneal neuralgia.

It can start from diabetes with systemic diseases or small fibro-neuropathy to autoimmune diseases, to ocular infections like herpetic infections or shingles.

And also from surgeries such as cataract and refractive surgery or any other surgery.

Some look at the eye as an extension of the brain.

Abnormalities in vision, discomfort, pain can significantly affect you neurologically.

Beyond the commonly known depression and anxiety, it can trigger migraines, it can trigger facial pain, it can cause facial anesthesia, it can trigger ear problems like ear ringing, ear pain as well.

The eye definitely can influence the function of the brain in various ways beyond just affecting quality of life and causing the pain.

But pain in general is very powerful.

What's difficult actually is from the physician's point of view, looking at normal looking eyes, being able to understand why the patient has pain.

And so many patients who have pain but don't have anything on exam are being potentially dismissed with the eye looks fine, you're seeing 20-20.

And psychologically patients may understand that maybe they're making things up or they're not being understood.

Or that they are not being acknowledged of having a condition just because it cannot be observed on a particular test.

- There is a community called LASIK Complications Support Group where thousands of people from around the world have found a home to discuss potential treatments, to discuss how to help their problems.

It's a hive mind of people that have traveled far and wide to every specialist around the country, around the world to try to get answers.

All these people have one thing in common.

They were told that their LASIK procedure carried relatively no risk, almost very low risk to no risk.

They were told that they were perfect candidates.

They were told they had nothing to worry about.

Now, most of them also have a deep regret for choosing something that they feel like they should have known better about.

Wishing they could go back in time.

Wishing they had seen more information.

- For some reason people are tricked into believing that LASIK somehow magically locks your prescription in for the rest of your life.

20-20 forever.

It's mind blowing how deceptive it is and how easily people are fooled by these doctors.

- This morning we're investigating concerns about the safety of LASIK eye surgery already performed on an estimated 20 million Americans.

- Paula Cofer had surgery 19 years ago.

- And from day one my vision was an absolute train wreck and it still is today.

She started a LASIK Complications Support Group on Facebook and quickly found she was not alone.

- And she's doing this out of the goodness of her heart.

And she has saved many, many lives.

She was on the panel.

They had a citizen, a non-MD participant in the F.D.

panel.

She was on that panel that I testified in front of.

- She reads every single article in the scientific literature.

Sometimes she'll send them to me for an opinion.

- I worked very close to a university that had a medical library and I would leave work and go straight to the medical library.

And I would just read ophthalmology journals.

Anything to do with LASIK.

I went on the F.D.A.

website and downloaded all the clinical trials and read all the transcripts from the clinical trials, the meetings with the Ophthalmic Devices Panel.

I looked at all the data, the summaries of safety and effectiveness.

Unfortunately, the more I learned, the more I realized that there's no fix for this.

Once your cornea has been altered by any form of refractive surgery, there's no undoing it.

It's a one way street.

If you look at the complications, if you look at taking a healthy eye that has no need for any surgery and you damage it and you expect it to function the way it did before, it's never going to.

It's not.

It's not going to ever function.

The patient may get by just like a smoker who smokes cigarettes and has damaged lungs.

They may not drop dead from smoking ever.

They may die of something else.

But that doesn't mean their lungs are healthy.

(wave crashing) I was a banker and I had been for over 20 years, and LASIK caused problems with my job, too, because I was expected to do some work at night.

And after LASIK, driving at night was extremely unsafe for me after I had LASIK and my employer didn't seem to get that.

If I didn't get home before the sun started to set, I could feel my chest just tighten because once the sun went down, my vision was just a nightmare.

(horn honking) When you are struggling with your vision, everything's a struggle.

I went through periods of depression, anxiety, thoughts of suicide.

It destroyed my marriage.

It...

It affected everything.

You have no idea how difficult it is to have normal relationships.

I mean, you can't even, you can't even, your family can't even relate to you.

Even my own mother didn't understand.

The one person.

My sister didn't understand.

Nobody understood.

The only people that can understand are people that have been through it.

And that's why I'm in this support group is so important because you feel so alone.

You feel like an alien.

I mean, I literally feel like some freak.

(plane engine roaring) (soft music) - I would say that extreme, but I had an aggressive near sighted prescription and it was not horrible.

I mean, I would go back in a heartbeat, right now.

I would go back to my previous vision.

I'd pay $100,000 I'd pay a million dollars to go back to my previous vision.

You know, I just fell into the trap that the LASIK sales engine gives to you that you'll never wear glasses again.

From the jump, it was bad.

I mean, from the jump, like, you know, they finished the surgery and the surgeon is like, "Great.

Now you can see!"

It's like, no, I can't.

I was just blurry... Everything was blurry, like nothing.

I could see nothing.

And got the same line that many, I would say, victims of bad LASIK surgery, they get the line, oh, it'll get better, it'll get better.

Well, within a day, it was clear like this is not better.

I'm blurry.

I can't see anything.

And I'm a graphic designer like I own a design company.

The designer that can't see anything is not an employable person.

And it was just extremely panicking.

I was very, very panicked.

So we went back in and their language that they used was so... Just so effective.

It was like, man, I don't know what's up with your eyes.

Like, what do you mean you don't know what's up with my eyes?

Like, you did this!

So I had a second LASIK surgery to try to correct what they messed up on the first LASIK surgery with a different doctor.

And I was left with what's called epithelial in-growth.

Epithelial cells naturally occur on the outside of your eye.

And whenever you cut into your eye, the cornea, those cells can get inside your eye where they don't belong and they just live there forever.

So around my corneas, around my eyes, there are clouds around my eye.

But that epithelial in-growth won't go away unless I have another surgery, which is going into my eye, cutting my eye open and trying to scrape away the epithelial cells.

But that's a bit of a fool's gambit because there's just as much chance of more cells getting in than they are getting out.

It's a big piece of information that is not communicated to people who are looking at LASIK.

Certainly I would tell anyone, don't do it.

The risks you're accepting by going into LASIK surgery are not communicated to you and they're not known to the public.

(birds chirping) - Most people do it or what you hear is, oh, I didn't want to wear glasses or contact lenses anymore.

And I absolutely love my contact lenses.

They work perfectly for me.

I was perfectly happy.

But I had a seizure in November of 2020 and went unconscious in the woods in November in northern Maine and woke up in the dark and my contacts had come out.

I did a lot of things to be safer.

I, of course, got on medication.

I wear a tracking device.

I carry safety gear with me.

And I decided it would be a good idea to look into having my eyes fixed so that if I did have another seizure, when I woke up, I would be able to see and find my way out of the woods.

Laser surgery gets discussed as if it's called cosmetic surgery.

And people say, oh, you just didn't want to wear glasses.

But there are reasons people don't want to wear glasses.

You don't have good peripheral vision or you could break them or lose them.

You could lose your contact lenses.

It can be foggy and you can't see.

I don't think it's fair to just say, oh, gee, that's cosmetic and you didn't have to do it.

When I was meeting with the eye surgeon, they did not give me the list of all the possible complications, that was mailed to me later to be signed and brought in on the day of my surgery.

So I had no opportunity to really discuss them.

I did ask how common were complications, how often did things go wrong.

And he's like, oh, hardly ever.

Maybe 1% of the time.

After LASIK surgery I need glasses pretty much all the time and I am in nonstop unremitting pain and I still have visual complications that can't be addressed.

- When I had the issue, I was thinking to myself, oh, my gosh, I look at a computer all day.

Is my vision going to be blurry for the rest of my life?

This is what a regular astigmatism looks like.

This is what I had prior to my surgery.

And my new topography is more irregular, as you can see in this picture.

I went to numerous doctors that weren't doing laser surgery and they said, yeah, this is not normal.

This is irregular.

But of course, when I go to my laser doctor, they say everything is fine and you have 20/20 vision.

Unfortunately, 20/20 vision doesn't mean clear.

It just means you can make out certain things.

This is actually 20/20 vision because you can actually see that this says D, E, F, P, O, T, E and I believe C. You can see it and you can make it out.

But it is not clear.

If you talk to most laser doctors, they'll tell you that this person has not just 20/20 vision.

They actually have 20/15 vision because you can make out the L, E, F, O, D, P, C, T. - The problem with my vision affected just one of my eyes.

And it leaves one of them unable to focus.

I am constantly aware of my eyeball in my eye at any time.

I can feel it move.

It's not something that's passive anymore.

And I think that's because it's been operated on so many times.

At first, I have this huge emotional, like, I've just been wronged.

How could this have happened?

And I'm just riding the righteous fury.

You guys have been treating me for over a year.

Your doctors messed up.

And a few weeks go by and he offers me $10,000.

It just took the wind out of me.

I couldn't believe it.

$10,000 on a probably $4,000 surgery that now has forever impact.

It's one of those things that if I were to do anything with a legal team or accept it from the company themselves as the 10,000, I don't get to talk about it.

And that's something I don't think is worth it.

Because if I had heard about stories like mine and the ones I've heard about since beginning this journey, I don't think I ever would have done it.

- Some people had told me it was the best decision of their life and I believed 'em.

And I thought that I would just be freeing myself from all these limitations.

And I did it and I too thought it was the best thing and I got everything that I thought I wanted and was just dealing dealing with what they convince you is minor complications with the dryness and the brightness.

And then it became starbursts and halos and ghosting.

And I didn't realize all this was happening because my dominant eye was still pretty good.

I went in to see my regular optometrist and he was just really quiet.

I had him write down the word.

He put keratoconus.

But then I later learned that it was the post-LASIK corneal ectasia.

And that I would have to go to their scleral fitter and wear these until I couldn't anymore.

And then I would need a cornea transplant.

And it was overwhelming.

Especially when they're selling this and then telling people later that this can happen.

- It's a scam.

It's a scam.

It's an unnecessary surgery on a healthy living tissue of your body.

- Now I have chronically dry eyes because of LASIK.

Like I would rather wear glasses for the rest of my life than have to deal with this.

- The complication rate is a lot higher than they tell you.

- Patients should be more informed of the risks of LASIK and how it can cause double vision, dry eyes and the feeling of glass in your eyes.

- I'm 19 years post-op and I still have horrible headaches, dry eye pain.

I spend so much money on eye drops, ointments, supplements, anything to just make the pain stop.

- This is just hell.

No one should have to live like this.

- Like honestly, I just feel like LASIK has ruined my life.

- People thought patients were crazy.

Oftentimes they're told that it's in their head, which is actually also what my doctor said.

- Honestly, they end up wanting to un-alive themselves.

- There are multiple cases of people committing suicide from LASIK related dry eye.

- Someone in my LASIK complications group just did that this week, like two days ago.

- You feel like you're forgotten, like you're swept under the rug and there's nobody out there listening to you.

- I would not recommend LASIK even to my worst enemy.

- Hey!

Guess what?

I've finally gotten you the greatest birthday present in the entire world.

I know it's a few days early, but I give you the gift of sight.

(audience laughing) - What?

- Open it up, open it up.

- Laser eye surgery?

- Laser eye surgery!

(audience laughing) One and a half minutes on each eye and bam, you're cured.

No glasses, no contacts, just perfect vision.

- Yeah, I know a few people who got this.

- And I took care of everything with your boss.

I got you four days off to recover, even though most people are good to go the next day.

But definitely by your party, you're looking at 20-20.

(audience laughing) So?

- Wow, well it would be great not to have to wear glasses.

But eye surgery?

Hey, isn't that kind of risky?

- Carrie Heffernan?

- That's me.

- You can follow me to the prep room now.

- LASIK surgeons are very clever about discussing risk.

They talk in generalities, it's very optimistic, it's very enthusiastic, and they don't explain in language the patients can understand.

So, the patients fall for it.

They believe the LASIK surgeons, they believe doctors.

They don't think doctors would do them harm.

They believe the glowing ads of the LASIK surgeons.

Wouldn't it be fun if you didn't have to put glasses on to see the clock?

Wouldn't it be fun if you could walk down the street without any glasses?

They believe them.

And they feel betrayed.

Of course they feel betrayed.

They have been betrayed.

- You feel this huge guilt like I just did this to myself, I didn't have to do this.

And there's no one on your side.

You know, you have to be an advocate for yourself.

And it was this full-time job.

Getting another surgery, deciding on more surgeries, going to specialists... And then ultimately deciding, all right, what level of disability am I going to accept so I can go forward?

There's like the life that you kind of wanted, but then there's the life you have.

As the months went on and the surgeries went on and the recovery went on, it was very clear that my life, it was not coming back, and there was a different one ahead of me.

Which requires a lot of optics and a lot of compromise and a lot of adjustment.

- I can't believe that, but I trusted my surgeon.

And I feel like a fool for just trusting someone blindly because they're a doctor.

I believed in, first, do no harm.

And now I know that that's just a bunch of nonsense.

This is a business where people are getting rich.

You have to be skeptical.

You have to look at what's going on and question them.

And any time someone says, we're running a special, there's no such thing as a special on your eyesight.

You should turn around and walk out of that place right there and then.

- It doesn't matter if you're doing, if you did LASIK 20 years ago or if you do it today with the latest, greatest technology, you're still damaging corneal nerves.

How did this new technology correct that?

It didn't.

That's just what they say because they're trying to sell more surgeries.

They'll say anything to sell more surgeries because that's what this is.

This is not medicine.

It's big business.

- Oh, that's disgusting.

You're a doctor and you're happy that you got an award in sales and marketing?

What does that tell you about these doctors?

(soft, tense music) - [Dana] One of the nation's leading laser surgeons shows this PowerPoint presentation to optometrists to help them steer more of their patients towards surgery.

(audience cheering) - [Dana] The pressure is relentless.

- Wake up.

You're totally blurry.

- Really?

Well, it's just the first day.

They said there could be some side effects.

That's just totally normal.

Some side effects.

That's just totally normal.

- Complications from laser surgery can happen to anyone who goes through with it, and they really don't know yet who is most likely to get it.

It should just be stopped since we know that there's a percentage of people that really are going to have complications.

One of the arguments is what is a complication because my eye surgeon continues to say I'm really not having a problem.

He doesn't consider my level of pain a complication or a problem.

So when eye doctors say they have low complication rates, by what criteria?

I've read things that the complication rate is usually around 30%, sometimes higher.

(upbeat music) - [Narrator] Food and Drug Administration, Washington, operating under the Federal Security Agency.

Its aims?

To combat filth and fraud in our food products and to guarantee as best it can that medicines and cosmetics not only contain what the makers say they contain, but do what the makers claim they'll do.

- I left the FDA in 2000.

I didn't know there was an issue or problem until Paula Cofer called me.

I was really very upset.

Now that's what I learned about.

One of the assumptions I had made all along was that the information brochures would be given to patients and they would be told what the adverse event rates were, what the problem rates were.

I discovered that patients were not being told anything.

Well, when I say I did research, I went back to look back at the records on the FDA's website where all of the data are presented.

And I said, well, okay what's going on?

Why are these patients making so many complaints?

So I went back and recalculated the rates for blurriness, rates for night driving problems and the rates for pain.

These were 5% or even 10%.

There were 20 and 30%.

So it was quite astonishing to me, actually, to look back and to know that no one is being told.

But that raises the question to me, what's an acceptable rate?

If you know beforehand, there's going to be somebody that it's one in a thousand or one in a hundred that's going to have intractable pain, what's acceptable?

Is intractable pain that you created in normal eye acceptable in anybody?

- [Dana] My eyes are in constant pain, I told my doctor, but I didn't always see that reflected in my medical chart.

- Most often there's this big wow effect because they're doing it in a setup which assures that most people are going to have a really good outcome.

Apparently, you know, it's a perception problem and they don't they don't measure them a year later, two years later, three years later.

That's a very good question.

Who's overseeing the collection of the data?

There was supposed to be an independent review board, but that didn't mean that those IRB's, institutional review boards, actually they're looking at what they were doing.

- There is no board review.

There is no peer review that I can see.

There's no oversight.

There's nobody checking in.

Nobody's checked up on me.

Nobody's given me a call.

There's, you know, there's nothing.

It's just this literally black hole that people get thrown into.

That should change.

And that's something we have to do by talking about it.

- LASIK is really profitable.

It doesn't have the same constraints as other eye procedures like cataracts, retinal detachments, corneal transplants have.

These procedures are paid for by insurance.

Insurance doesn't pay for LASIK in almost all cases.

This means the LASIK surgeons are able to charge big bucks.

- My cataract surgeon also does refractive surgery.

She's a wonderful surgeon, but she's doing something that she knows is not right.

So they're just entangled.

They're entangled.

There's not enough money in cataract surgery because it's so, they've gotten it perfected so well.

When there was a cap put on how much they can get reimbursed for cataract surgery, the lenses got smaller and foldable, easy to implant.

The surgery went real quick.

They could no longer make the kind of money they made initially with cataract surgery and contact lenses.

Contact lenses became a consumer product.

So they needed another cash cow and they found it with LASIK.

- The LASIK surgeons discovered that the best business model for the highest profits was for the surgeon to just perform surgery, high volume surgery, just flap and zap, just get them in like cattle.

For them to have to deal with pre-op exams and post-ops, follow-ups, that was just too much of the surgeon's time.

So they partnered with optometrists.

The optometrist will do the pre-op exam and then refer the patient for surgery and then the surgeon does the surgery and sends the patient right back to the optometrist.

Optometrist gets a fee for doing that.

It's just a way around an illegal arrangement, but it's called co-management and they get away with it by calling it co-management.

- Hi, I'm Steven Dell and I'm here at the Aspen AECOS meeting.

- I thought it went really well.

The one experimental, if you can call it, session that we had, section, was life after LASIK with the idea that should we be diversifying out of LASIK with all of its challenges.

I'm not sure we came up with an answer... - There was really a great discussion from Alan Reider and Allison Shuren on the legal landscape, the issues relating to co-management and the pitfalls that you can find... - Well, the Southeast Eye case.

It was like the greatest hits of how you can go to prison.

- Every ophthalmologist was sort of squirming a little bit, thinking, going through their mental checklist of things that they are doing right now in their practice that might be problematic.

- My interest was in the context of the FDA's authority under law and regulations, and in particular with regard to the safety and the effectiveness of these devices and how they're used.

Well, the statutory requirement is that the labeling cannot be false or misleading.

When that kind of evidence is presented to the agency or acquired by the agency, they have the responsibility to take action.

And the action could begin with an inspection of a facility and or a communication.

And with that kind of, quote, warning, those who are responsible are expected to correct the problem, the labeling.

That's what the responsibility of the agency is, to respond.

And if that hasn't been occurring, that's part of the mischief for which I characterize my opinion of the agency, that they're incompetent.

- The gentleman that is the director over the entire Center for Devices and Radiological Health is married to an attorney.

She defends LASIK surgeons and she even attends their conventions.

The FDA is, they just work hand in glove with the LASIK industry.

- For people who get LASIK surgery, there is kind of like, well, you rolled the dice, you took the chances.

And that's just not true.

I mean, what you did was you were sold a bill of goods, not really told about the potential negative outcomes, and you suffered those negative outcomes.

And I think if people knew about the negative outcomes of this particular corrective treatment, they would think about it much differently.

Look at that.

So when you research failed LASIK surgery, you get ads for LASIK surgery.

(laughs) There is a radical deficit of education regarding the negatives of LASIK surgery, a radical deficit, and it's not there by accident.

And the education that people need before making this choice, a potentially life-damaging choice, needs to be screamed from the hilltops.

- Making this film has not been easy for me, learning to live with my new reality and suffering through depression...

So when I got stuck, I turned to Docuclub, a group of documentary filmmakers in Minneapolis for feedback, and they also had questions for me.

- After talking to so many people who had similar issues, how did that affect your journey and dealing with your own, you know, your own injury in the process?

- It really helps heal me emotionally to be connected to these other people.

But in the same token, every time I went to interview a LASIK victim, the impact on me was so heavy, like surprisingly heavy that I'd be like out for a week.

Like I couldn't like really function for a week after interviewing somebody.

Like, sorry, I'm getting emotional because I think of the mom, Tammy, when I interviewed her, her kids were there, and they were like 12 years old.

And they were watching her cry about, you know, she's probably going to go blind or need a corneal transplant.

And they never heard her tell this story before that this happened to her.

And they were just like bawling afterwards and like hugging her.

And so just like seeing the impact on people's families is like so hard.

So I obviously carry that with me.

Each of their stories is like so impactful.

And I feel responsible for them, like to give them a voice.

Like they need a voice.

Like this is helping them to be able to talk about this and to be like legitimate in doing so.

So I think it's really, yeah, it's really been a roller coaster for me.

- LASIK was approved in 1998 by the FDA.

And I started seeing patients damaged by LASIK quite soon after that.

And they would cry in my office.

They would say, I can't see.

I'm disabled.

I'm in terrible pain.

I'm suicidal.

I trusted my doctor and my doctor betrayed me.

But basically I talked to them.

I explained what's going on in their eyes.

I explained why they've had this result.

And I try to make them feel heard.

And I try to keep them from killing themselves.

I did treat my anxiety a little bit during this.

I haven't had to as much now.

I've kind of gotten support from the LASIK complications group, learning about different treatments and reading about people that have it a lot worse than me, finding more people who have had complications, that it's just not a fluke.

There are other people that aren't being heard and aren't being supported.

I'm trying to get my hope back up to try again before I go to like a cornea transplant.

- Before Colin had LASIK surgery, he was a very confident, outgoing person.

There was no sign of any mental illness.

He'd never been diagnosed with mental illness.

He didn't use illegal recreational drugs, and he seldom drank.

I think the thing that best explains where Colin was is to read the last words he left for us.

"If I can't get my eyes fixed, I'm going to kill myself.

Every single thing I look at looks ugly and confusing to me.

I can't continue living without my responsibility, my esteem and my happiness.

There's nothing at all ennobling or enlightening about suffering.

The more I live with this problem, the more it will warp me and the more hateful and bitter I'll become."

- A popular TV meteorologist took her own life after telling viewers she was suffering in the aftermath of laser eye surgery.

- I just want to get my vision back 100%.

- [Reporter] 35-year-old Jessica Starr posted a heart-rending video on social media a month after having the eye surgery.

- I am...

I am struggling a little bit.

- [Reporter] Jessica was married with two children, and her death is putting a spotlight on LASIK eye surgery.

At least 11 people have reportedly committed suicide after suffering pain, even blindness, after the operation.

(soft music) - If I knew the answer to that, I would have had myself fixed so long ago and would put all this in the rearview mirror and never looked back.

There are no solutions.

There's no solutions to this.

I have looked, I have turned over every rock.

There's nothing I have not done.

There's nothing, there's no...

There's no limit to what I still would do to find a solution to this.

But for 20 years, I've looked.

- Initially I was so incredibly distraught.

I couldn't stop spouting off about what had happened to me and how horrible it was.

And I cried and I was very, very, very upset.

A year and a half later, I'm learning to live with it.

But I never don't think about it.

There's never an hour that goes by that I'm not thinking about the fact that my eyes hurt or, oh gee, I can't put that tool together.

I need to find someone to do it for me because I can't see well enough to put it together anymore.

It's kind of going to be, I think, a level of upset about it constantly.

It's invisible.

- It's invisible.

And that's why people ask all the time whether, oh, are your eyes better?

Because they can't see that my eyes aren't better.

And they want my eyes to be better.

They want the best for me.

They mean it kindly.

- What I really, really miss is being able to see things clearly close up.

Like, I can't do that anymore.

So in design, you know, everything is all in details.

So what I end up doing is just taking pictures of things, blowing them up really big, finding workarounds, you know, relying on other people who work for me for some of the more finer detailed stuff.

But it's changed the way I do business.

I'm still doing design and art, but I'm doing it in a much different way than I used to.

What I would want anyone to know about the journey of LASIK surgery is that it is a very imperfect science.

Like, if something goes wrong, they're not going to address anything, they're not going to pay for anything.

And it really should be highly regulated.

Like, the answer here is regulation.

When industries that are damaging to people do not regulate themselves, that's when government has to go in, or an external force has to go in and regulate them.

- The FDA is not doing its job, and it's as simple as that.

But FDA, I think, has decided that it doesn't want to shake this big industry.

Because they've been complicit now with it since 1992.

So it's really tough for a large organization to say, whoops.

- I'm being informed about large numbers of incidents, but I did not know until you called me, and since then, how much has been ignored, ignored by the people in the FDA.

And from my perspective, because I spent 10 years with the FDA, almost 10 years with the FDA, and that's not the way this program was to be applied.

And I'm getting more irritated about this, because something's gotta be done.

You're doing the initial service here, but it's got to be much bigger than this.

- When I started treating patients who have lost vision from refractive surgery, never in my wildest dreams did I think this would ever occur.

These kind of complications, this kind of damage to people's lives, to their souls, to their families...

Patients who've lost their jobs, patients who've lost their families, patients who got divorced because their partner didn't understand what they were going through, I see this in front of me, over and over again, over the years.

This population has this on their mind every hour of the day, even when they're sleeping.

It's like a bad dream that can be with them all the time.

Every other aspect of your life is affected.

Everything around you, everything has a different color to it.

- Blurry?

- Yeah.

- Sharper?

- Yes.

- Okay, give me 20-20.

It's minus two and a quarter.

- I'm about 370.

- Okay, is that better?

- Mm-hmm.

- Everything look good?

- Yeah.

- Okay, get me the white dot.

(light buzzing) (soft, tense music) - Clinics, from my experience from talking to many, many LASIK patients, they're schmoozed on the way in to the clinic by the staff, and they gaslight them if they have a little bit of complaint.

Ah, no, that's going to go away in a couple of months.

- Come back in a couple of months and, ah, give it another week or two.

Now that a year goes by and people get upset, then they say, I'm not going back.

Give them their money, get your surgery, and go away.

And so every time you come back, you're costing them money.

- See ya.

Go ahead and take them off again.

(soft music) - This surgery takes such a huge emotional toll, and it's not just on the patient, on their families, their children.

There are people out there that are living lives that they weren't intended to live because they had LASIK surgery.

They're spending lots of money, and they're constantly babying their eyes, and they're not living the full life they intended to live because of LASIK.

When you have a bad LASIK experience, in the beginning, that's all you wanna do is get back to where you were.

You want to... You wanna undo it.

You wanna reverse it.

You wanna wake up, and it's just all been a bad dream, and your eyes are just the way they were with your glasses or your contact lenses.

That's what you want.

You want your old life back.

And as long as you keep chasing that, you're just, you're gonna stay in a dark place.

I had to completely let go of the girl I was before LASIK, and accept what happened and accept that I have a disability.

That was hard.

That was hard to accept that I have a disability, and to think that I brought it on myself.

I mean, I blamed myself for a long time.

- It's not who you pick.

It can happen to anyone.

What you think you're going to get is not worth the risk.

These complications aren't minor.

They're life-changing, and they're debilitating, and they're always there.

There needs to be more support for the millions of people that are going through this surgery, and that needs to get amped up now.

Because the people 15 years out now like I am are all going to be having more complications.

- I can't walk back that really bad decision.

I can't change it for myself.

So my only hope, I guess, is telling everyone I run across, anyone I see wearing glasses, anyone who talks about having laser surgery, what a horrific risk they're taking, and that the people who will do this to you will not warn you.

- Someone has to take a stand against this industry.

They lure people into a surgery that they know is risky, and they know that it's harmful... Don't trust doctors.

They're human beings.

Some of them are good, some of them are bad.

But the surgeons that perform LASIK, they have abandoned medicine.

- Honestly, I think the industry is going to change, at some point, it either has to get better, and these risks have to be mitigated, or they're going to be exposed so that people know the risks, so that nobody else gets blindsided by it.

Like one of those two things has to happen.

- Patients banding together, I think, are the first step to having impact.

Sadly, we don't have the financial resources, nor do we have the megaphone to address industry.

We are not going to be able to affect change by our outcry alone.

We would have to affect the bottom line of the industry in such a way that they had no choice but to change.

So I think the best thing that we can do from a patient's perspective, who's had a negative outcome, is to say to everyone, don't get LASIK surgery.

Don't do it.

Because it's a roulette wheel with no regulation.

And the best thing we can do is affect their bottom line to the point where if they still wanna run this business, they're going to have to run it in a more responsible manner.

That's sadly, in a consumer-based economy, that's the only tool we have.

And it is a mighty tool.

- I realized that there was a huge need for representation among these patients.

They were being muffled, they were crying out for help, they wanted people to listen to what they were going through, and they were basically being brushed under the rug.

So I thought, I can't get my eyes back.

I can't undo what I've done.

But I can make a film about it and maybe help other people.

And to me, that was the best option I had.

- The FDA just laid out the risk of LASIK surgery in a new draft.

The agency says patients should be warned that they may be left with dry eyes, double vision, difficulty driving at night, and persistent eye pain as well.

On top of that, the FDA warned that even after surgery, the patient may still need glasses.

It is important to note, though, that this is a draft.

It's not a final recommendation.

The FDA is reviewing hundreds of comments before it reaches its own conclusion.

- I wish I had been told this, I have dry eye or a problem with a glare or halo after the surgery... And so that's when the FDA is deciding whether it should step in and require these surgeons to go through a checklist of sorts.

And I was trained as an OBGYN surgeon.

A surgical consent form, and this is so important for patients who are having surgery, even if it's elective, should always explain what are the risks, what are the possibilities, how often does that happen in general in the literature, and how often does that happen with the surgeon you're going to.

If that's not part of the consent form, that surgeon has not done their job.

(upbeat music)