Lasik Injury Advocate Urges Action on Misleading Ads
Vision Advocacy president Paula Cofer, who also moderates a Facebook support group of over 7,000 people who suffer from complications associated with refractive eye surgery, such as LASIK, PRK, SMILE, and phakic intraocular lenses, has asked FDA commissioner Robert Califf to take regulatory action against refractive eye surgery providers who have a “long history of false, misleading advertising.”
In a recent letter to Califf, Cofer said it is “safe to say that 99% of advertisements for refractive eye surgery violate 21 U.S.C. § 321(n)) by omitting critically important risk information. In 2012 and years prior, the FDA issued warnings to eye care professionals regarding illegal advertising, but these warnings did not seem to have any effect, and there have been no warnings since then that I am aware of.” Cofer noted that her previous letters to the agency on false and misleading advertisements for refractive surgery devices have all but fallen on deaf ears.
To illustrate the problem, Cofer’s letter takes issue with a recent advertisement “that is so egregious that I could not ignore it.” She said the online advertisement by Gregory Parkhurst of Parkhurst NuVision, San Antonio TX, is masquerading as a press release for phakic intraocular lenses known as EVO Visian ICLs. This ad is worrisome, Cofer continued, because it “completely trivializes this potentially dangerous medical device and does not contain one word about its risks or limitations. Moreover, it portrays the surgery like a game with patients ‘racing’ to have an unnecessary medical device implanted in their eyes, and even compares it to ‘people camping outside of the Apple store before a new iPhone release.’”
Cofer pointed out that potential complications from the lenses can occur “immediately or shortly after implantation, such as infection, inflammation, visual disturbances, and retinal detachment, but other complications, such as glaucoma, cataracts and significant loss of corneal endothelial cells (potentially leading to corneal decompensation and need for corneal transplant) may develop slowly and insidiously over several years. In fact, these late-onset complications were largely missed in the clinical trials with three years of follow-up.”
Cofer also says that in the ad, Parkhurst makes the following deceptive claim: “EVO is designed to provide permanent vision correction, and for added peace of mind, it is both removable and replaceable if needed.” She said it is highly unethical to “downplay the risks of repeat, unnecessary intraocular surgery.”
Cofer urged Califf and the agency to take “immediate action to stop the illegal advertising of the EVO Visian ICL by Dr. Gregory Parkhurst of Parkhurst NuVision.”
Cofer, who has been engaging with FDA on LASIK and PRK for years, told FDA Webview 3/3 she has had only a form letter acknowledgment from FDA on this letter, “which is unusual, because they usually at least mention the substance of what I tell them, even if it’s only from the ombudsman. On LASIK and other eye-related advertising issues, nothing changes.”