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FDA Warns LASIK providers: Stop making false claims

Posted by Charl Laas
Charl Laas
Back at work and knee deep into contact lenses. Life is good.
User is currently offline
on Friday, 11 November 2011
in Eye Care ·

In recent months LASIK refractive surgery providers in the United States came under fire from the US Food and Drug Administration. The concern is not related to the safety aspect of LASIK but rather to the incorrect perception LASIK advertising is creating in the US and internationally. If one takes into account the new Consumer Protection Act, South Africa adopted this year it is also very relevant to the South Africanmedical refractive surgery fraternity.

Recently, Denise Mann wrote the following article for Health Day highlighting the matter:

Agency giving practitioners 90 days to curtail inflated promises, missing safety info in ads

The U.S. Food and Drug Administration is once again cracking down on eye care professionals who make false safety claims and promises about the popular LASIK eye surgery.

The agency's Letter to Eye Care Professionals, issued this week, follows an earlier warning from May of 2009. In its latest salvo against deceptive, potentially harmful advertising, the FDA is now giving eye doctors 90 days to get in line and update any advertising or promotional materials that make false claims. After this time, the agency will take regulatory action, said FDA spokeswoman Erica Jefferson.

"It's about the false claims and not adequately providing consumers with information about the risks associated with the procedure," she said.

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Ophthalmic surgeon performing LASIK refractive surgery
Tags: FDA, LASIK
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Effects of fitting RGP lenses on Post LASIK corneas

Posted by Charl Laas
Charl Laas
Back at work and knee deep into contact lenses. Life is good.
User is currently offline
on Wednesday, 25 August 2010
in Eye Care ·

One of the most common visual side effects of Post LASIK patients is halo's and ghosting which is more pronounced during low light levels. These visual disturbances are called higher order aberrations (HOA).   In the opinion of contact lens fitters, many patients find relief of the higher order aberrations and improvement of their visual acuity when they wear Rigid Gas Permeable (RGP) lens fitted over the Laser treated corneal area. 

I recently read this research paper titled 'Changes in wave-front aberrations after rigid gas permeable contact lens fitting in post-laser in situ keratomileusis patients with visual complaints' published in Can J Ophthalmol. 2010 Jun;45(3):264-8.

The authors were Tan G, Yang J, Chen X, He H, Zhong X

Objective:

To evaluate the effect of rigid gas permeable (RGP) contact lenses in reducing wave-front aberrations in post-laser in situ keratomileusis (LASIK) myopic patients.

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