Parker Waichman LLP

LASIK Side Effects Not Taken Seriously, Former FDA Official Says

Late last year we wrote about the potential impact on quality of life from LASIK surgery and a study launched by the Food & Drug Administration (FDA). According to an agency press release, the study was to be a collaborative effort between the National Eye Institute and the U.S. Department of Defense. Most recently, ABC […]

Late last year we wrote about the potential impact on quality of life from <"https://www.yourlawyer.com/topics/overview/LASIK">LASIK surgery and a study launched by the Food & Drug Administration (FDA). According to an agency press release, the study was to be a collaborative effort between the National Eye Institute and the U.S. Department of Defense. Most recently, ABC News broke with a report about an FDA regulator who was involved in approving the procedure in the 1990s and who is now discussing his concerns over LASIK’s safety.

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. LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.

According to ABC, while most procedures appear to take place with no issue, there were adverse reactions about which the agency was aware, yet minimized, said Morris Waxler, former head of the FDA area that reviewed LASIK data, said ABC. Waxler, who retired from the agency a decade ago, recently discussed the matter in an interview with the news outlet.

“I wouldn’t say it was pooh-poohed so much it was just sort of shoved aside as the kind of, we, we don’t know what to do with that data,” he told ABC News. “It’s right there in the record. The agencies and the refractive surgeons, people know these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created,” Waxler added, quoted ABC News.

ABC News explained, has resulted in some patients complained of both long- and short-term adverse reactions, and even permanent adverse effects that include “starbursts, halos, glare, double-vision, and night blindness.” Some adverse effects have created significant quality of life issues that have forced some people out of work or unable to drive or continue with other activities of living that were a normal part of their lives prior to LASIK.

Wexler told ABC News that the agency should have put in place stricter LASIK standards and feels the FDA should now mandate manufacturers and surgeons to discuss LASIK’s possible side effects with patients. “The agency actually has a lot of power,” Waxler said. “The agency could readily require that those manufacturers keep better tabs on what happens with their product,” he added, reported ABC News.

The FDA maintains that LASIK is safe when performed appropriately, but did respond to the issue of LASIK complaints and announced that it has, among other steps, established better reporting mechanisms, which should lead to better monitoring and improved safety and efficacy of the procedure, said ABC News. As we have previously written, the LASIK Quality of Life Collaboration Project will occur in three simultaneous phases; is expected to be completed in 2012; and will be a collaborative effort with the FDA, the Department of Defense, and the National Eye Institute.

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
I would like to thank Kathy and Alex for all their hard work and dedication through out the entire process. I am very happy with the outcome of the case. I would highly recommend to my family and friends.
Alanah Rotunno
7 months ago
5 Star Reviews 150
Michele J at Parker waichman Was the best in helping me understand the process about the final stages of my dear fathers lawsuit settlement.mr Parker and mr waichman Michelle is extremely knowledgeable and a pleasure to deal with.my recommendation would to please let her know how thankful we are and we just wanted to let you know you definitely have a special lady working for your law firm .please let her know about my letter to you and again Michelle deserves recognition in her professionalism and knowledge.yours truly Steven Sica
Kelly Sica
4 years ago
5 Star Reviews 150
Positive: Professionalism Always kept me informed in a timely manner
Donald Dodson
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