Parker Waichman LLP

FDA Targets Deceptive LASIK Advertising

Ophthalmologists have been given 90 days to revise any advertising for LASIK eye surgery that makes false or misleading claims about the procedure’s safety and effectiveness. According to a Health Day News report, the ultimatum was made by the U.S. Food & Drug Administration (FDA) in a “Letter to Eye Care Professionals” issued last month. […]

Ophthalmologists have been given 90 days to revise any advertising for <"https://www.yourlawyer.com/topics/overview/LASIK">LASIK eye surgery that makes false or misleading claims about the procedure’s safety and effectiveness. According to a Health Day News report, the ultimatum was made by the U.S. Food & Drug Administration (FDA) in a “Letter to Eye Care Professionals” issued last month.

“It’s about the false claims and not adequately providing consumers with information about the risks associated with the procedure,” an FDA spokesperson told Health Day News.

LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye’s cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown

LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery. However, as Health Day points out, LASIK isn’t for everyone, and from time to time, patients may experience vision loss, under- or over-correction of vision, dry eye, infection, glare, halos and or double vision.

On May 22, 2009, the FDA issued its first letter to eye care professionals regarding the promotion and advertising of LASIK surgery. That letter followed an April 2008, FDA Ophthalmic Devices Panel public meeting, at which the agency received information that eye care professionals’ advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures.

In its latest letter dated September 23, the FDA said it continues to receive information concerning improper promotion and advertising practices by eye care professional.

“It is critical to disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the devices’ use. Advertisements and promotional materials that do not include appropriate risk information may be misleading,” the letter states.

“Any person, including an eye care professional, who misbrands a restricted device through false or misleading advertising, or by causing the device’s labeling to be false or misleading, violates the FD&C Act and is subject to enforcement action,” it continues.

Long Island ophthalmologist Dr. Eric D. Donnenfeld, who spoke on behalf of the American Society of Cataract and Refractive Surgery, told Health Day News the group supported the FDA’s action.

“A lot of patients make a decision based on an ad in a magazine or an audio clip on radio,” Donnenfeld said. He pointed out that “there are a lot of very good doctors who advertise, but it doesn’t mean a doctor is good because he advertises or offers group discounts.”

Donnenfeld told Health Day News that patients considering LASIK should choose a surgeon who is a member of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery. LASIK surgeons should also be board-certified by the American Board of Ophthalmology, he said.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Parker Waichman handled a slip and fall case for my husband - which was handled with the utmost professionalism. Speaking with the paralegal assigned to the case, Lynda Luckman, was an absolute pleasure. She was helpful from the inception of his case, up until receiving closing papers. She always knew exactly what the status of the case was and was always there to answer any and all questions we had. Her patience and kindness was exemplary. Brett Zekowski, the attorney on the case, was very attentive to our requests and delivered a result that we were very pleased with. We will certainly recommend Parker Waichman to anyone in need of legal assistance!
Audra Massimo
5 years ago
5 Star Reviews 150
Parker Waichman is a top notch firm! I was very impressed with my paralegal, Benita, who gave me her undivided attention. She is caring, careful, prompt and meticulous in all that she does. It was an absolute pleasure dealing with Benita and I cannot say enough of good things about her. Good job Benita! I am forever grateful for all your assistance.
Clifton Botelho
3 years ago
5 Star Reviews 150
Parker Waichman has been so much help with my case over the past few years. It has finally come to an end with a positive outcome. I would also like to thank Benita Rollis, who personally kept me up to date every step along the way. She was able to answer every question I had and always replied in a very timely and professional matter. I cant thank your firm enough. All I can say is thank you from me and my entire family.
Ed McKenna
2 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038