FDA Proposed Guidance 7/28/2022



The FDA has announced proposed guidance to improve patient communication about LASIK surgery risks. This represents a significant step forward in patient protection and informed consent for laser eye surgery procedures. They are aware that prospective LASIK patients are not being adequately warned of the risks.

FDA Announcement Highlights

The FDA seeks to improve patient understanding of LASIK benefits and risks through several key initiatives:

  • Patients should receive a “decision checklist” describing the procedure and its risks
  • Enhanced disclosure requirements for potential complications
  • Improved standardization of patient information materials

Fox News Coverage 12/12/2022

FDA warns that LASIK surgery patients need to be better informed of risks.

From the article: “The surgery known as LASIK — Laser-Assisted In Situ Keratomileusis — is under the lens of the Food and Drug Administration (FDA), which is causing controversy among eye experts. The FDA released a 25-page draft guidance after receiving input from patients who felt they were not fully informed of the risks associated with the surgery, the agency stated on its website. The FDA’s guidance states that patients considering LASIK surgery should be given a “decision checklist” that describes the procedure. Patients should also receive a list of potential side effects that may include dry eyes, difficulty driving at night, double vision, seeing halos around objects and in some cases persistent eye pain and a need for glasses, the FDA said in the same paper.”

Potential Side Effects and Complications

The FDA guidance emphasizes that patients must be informed about potential side effects, including:

Reactions to Proposed FDA Guidance

Comment by whistleblower-former employee of LASIK surgeons: https://www.regulations.gov/comment/FDA-2022-D-1253-0607

“There were a lot of happy customers but the number of people with debilitating complications was alarming. During my tenure working I saw around 5600 patients come through and around 10-15% had severe issues following LASIK.”

“Another marketing tactic was for surgeons to just simply only tell customers about the benefits. Customers rarely know what to ask, they don’t read studies or know how to access them. Every was told “this procedure has a 99% success rate.” This statement is technically true because success is determined by the surgeon, not the patient. There were commonly suicidal patients who were determined a success by surgeons.”

LASIK whistleblower.

Links to a few of the nearly 300 comments by LASIK patients with bad outcomes:

  • Comment FDA-2022-D-1253-0343 - Chronic dry eyes, a loss of vision clarity, light sensitivity, difficult to drive at night. “Nothing has helped and I fear my vision is permanently ruined.”
  • Comment FDA-2022-D-1253-0361 - Severe dry eye that requires three medications, warm compresses, and I’m unable to wear contacts. Patient was given nothing resembling honest informed consent.
  • Comment FDA-2022-D-1253-0391 - “I had Lasik surgery in May of 2019 and it has destroyed my life. I have been suffering with not only bad vision that can only be corrected with scleral lens (very expensive and uncomfortable) but the pain in the has been indescribable. I tried committing suicide because no pain medicine can help.”
  • Comment FDA-2022-D-1253-0396 - “I’m a 32 year old now living with severe life changing complications from lasik. It caused me severe burning and aching pain that I have now been in for four years without a second of relief. The pain never stops.”
  • Comment FDA-2022-D-1253-0401 - “Lasik has ruined my life. I was not informed about the risks, about the nature of surgery(cutting cornea,nerves etc) and the worst thing is that the provided information about the risks are little to no… I wish i knew more details about the risks.. Lasik has ruined my life as IT specialist. I cant work with computer more than 2 hours due to dryness , ocular pain.. It makes me so depressed. Sometimes i am thinking about suicide….”
  • Comment FDA-2022-D-1253-0408 - “I now suffer from debilitating HOA’s because of my large pupils. I have loss of contrast sensitivity, epithelial ingrowth, and there is a metallic speck left in my eye. LASIK has ruined my night time eyesight and the entire industry is sickening.”
  • Comment FDA-2022-D-1253-0410 - “Dry eye is a disabling painful and chronic condition. It is not something to make light of and brush under the carpet. I feel misled by my surgeon, he didn’t property explain the risks not what dry eye is actually like. Lasik is marketed like a non invasive surgery but it is incredibly invasive and has left me with a permanent and painful medical condition. My life evolves around managing my dry eye now, I have lost so many of life’s freedoms. I experience pain and discomfort daily. I am a shadow of my former self because I am constantly experiencing discomfort, I struggle to concentrate, my work is affected.”
  • Comment FDA-2022-D-1253-0456 - “I have extreme dry eye, frequent corneal erosions and fluctuating vision. I have a number of siblings who also had this procedure done around the same time and only those of us who have had this procedure done are experiencing varying degrees of dry eye and other cornea issues.”
  • Comment FDA-2022-D-1253-0452 - “After vetting 5 different Lasik centers in 3 different states, my daughter received Lasik surgery at the age of 23 and over 4 years later is still suffering from the complications from the surgery. Even though she repeatedly was told she was a candidate, she was not. It was determined after the fact that her pupil size and myopia were well above the acceptable limits resulting in the need for corrective glasses and constant pain and dry eye symptoms. These complications have adversely affected her life for years, resulting in quitting her job and causing severe emotional and physical pain.”
  • Comment FDA-2022-D-1253-0465 - “I had lasik and was blinded by it within 24 hours due to a complication called CTK. After 8 months I have some vision again, but I’m left permanently low vision disabled. Glasses nor contacts can restore me to good vision. I was unaware of the chances of having a severe complication from Lasik and might not have proceeded had I been warned. I fully support the FDA requiring stronger warnings to people considering lasik. The procedure ruined my life. Please FDA, please! Make the surgeons warn people. Thanks.”
  • Comment FDA-2022-D-1253-0582 - “I recieved Lasik surgery in February of 2021. Prior to Lasik I wore glasses with no issues whatsoever. After lasik surgery I am in constant severe pain for which there is no known treatment for. I also have hundreds of floaters in each eye. These complications have left me almost entirely disabled. I cannot leave my house easily or do the tasks I used to perform with ease.”
  • Comment FDA-2022-D-1253-0599 - “I have lost vision from the surgery that can’t be restored, I can no longer wear contacts, I have to use expensive medications daily for my eyes and I’m working on moving to a different climate to improve symptoms in my LASIK surgery destroyed eyes. I fully support the FDA issuing new labeling for LASIK lasers with full disclosure of the risks.”

Patient Testimonials

Real experiences from LASIK patients highlight the importance of this guidance:

“I went from living a full healthy life to living a fraction of the life I was living before LASIK.” — Ann Simon, 11/03/2022

“Lasik has become one of my biggest regrets in my life and I wish the probability of complications was discussed more thoroughly with me.” — Derek Romero, 11/17/22

These testimonials underscore why improved patient communication is desperately needed in the LASIK industry.

Why This Matters

This proposed guidance represents years of work by organizations like Vision Advocacy, countless patients who have experienced LASIK complications, and eye doctors speaking out against LASIK. The FDA’s recognition that current patient communication is inadequate validates what we have been saying for years.

Support Our Mission

Vision Advocacy is a nonprofit organization dedicated to educating and supporting individuals affected by laser eye surgery complications. We continue to advocate for better patient protections and informed consent.

How You Can Help:

  • Share this information with others considering LASIK
  • Support our advocacy efforts through donations
  • Contact your representatives about patient safety in elective surgery

Donation Information:

  • Vision Advocacy is a tax-exempt 501(C)(3) nonprofit organization
  • Donations are tax-deductible as allowed by law

For more information about LASIK risks and complications, visit our 10 Reasons to Avoid LASIK page.