FDA Warns LASIK Eye Care Providers To Adequately Inform Consumers

 

According to HealthDay News and an FDA News Release, federal regulators are warning five U.S. eye care providers to stop misleading advertising about the special lasers used in vision correction procedures such as LASIK, the U.S. Food and Drug Administration has announced.

Those ads and promotional materials do not offer consumers enough information about the potential risks, according to the FDA.

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health, said in an agency news release. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Vision correction surgery with refractive lasers is intended to reduce a person’s dependency on glasses or contact lenses. In refractive surgery, precise and controlled removal of corneal tissue by a special laser permanently reshapes the cornea (a part of the eye that helps focus light to create an image on the retina) and changes its focusing power. LASIK, which stands for Laser-Assisted In Situ Keratomileusis, is one type of vision correction surgery that uses refractive lasers to correct nearsightedness, farsightedness, and astigmatism.

The most common risks of LASIK surgery include: dry eye syndrome, which can be severe; the possible need for glasses or contact lenses after surgery; vision problems such as halos, glare, starbursts; double vision; and loss of vision.

The FDA said the warnings were sent to the following five providers:

  • 20/20 Institute Indianapolis LASIK, in Indianapolis
  • Scott Hyver Visioncare Inc., in Daly City, California
  • Rand Eye Institute, in Deerfield Beach, Florida
  • Eye Center of Texas, in Bellaire
  • Woolfson Eye Institute, in Atlanta

If the providers do not correct their advertising and promotional materials to address the FDA’s concerns, the agency may take further action, including seizures, injunctions and fines, the agency said in its news release.

The FDA previously issued letters in May 2009 and September 2011 to eye care professionals nationwide explaining the agency’s concerns about improper advertising and promotion of FDA-approved lasers. The FDA also issued letters in March 2012 to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology, providing additional information about disclosing risk information in eye care professionals’ advertisements and promotional materials concerning FDA-approved lasers intended for LASIK.

The FDA website includes information on the risks and benefits of LASIK, and provides access to the labeling for FDA-approved lasers used in LASIK. The FDA encourages consumers considering LASIK to understand what might make them poor candidates for the procedure, the risks and limitations of the procedure and the particular laser that would be used to perform the procedure. The FDA also recommends that consumers consult an experienced eye care professional to know what to expect before, during, and after LASIK surgery.



, ,

No comments yet.

Leave a Reply

GET HELP NOW!
  • This field is for validation purposes and should be left unchanged.
Latest Drug Injury News

Merck’s Falsification of Vaccine Data Exposed

Merk’s dirty little secret has been exposed. A pair of lawsuits, one filed by former employees of Merck and the other by doctors, alleged the company knew its mumps vaccine was less effective than the supposed 95 percent efficiency level. According to court documents the former virologists employed by Merck filed a whistleblower lawsuit four […]

Testosterone Therapy Linked To Heart-Attack, Stroke and Death

Millions of men have turned to testosterone therapy to treat symptoms of aging. However, they may not be aware that they are putting themselves at risk for heart attack or stroke. According to the latest study published in the journal PLOS ONE, researchers report that within 90 days of taking the hormone the risk of […]

What Is Doribax?

According to the FDA the antibacterial drug Doribax, that has been used to treat patients who develop pneumonia on ventilators, carries an increased risk of death and has a lower clinical cure rate by injection compared a similar drug known as Primaxin. What is Doribax? Doribax is an antibiotic that fights serious infections caused by […]

Is Using Tylenol or Ibuprofen During Pregnancy linked to ADHD?

What is a mother to do if she becomes ill during pregnancy?  The risks of consuming common drugs when pregnant are complex.  Although many doctors assure mothers that taking Tylenol is safe, a recent study by JAMA Pediatrics suggests otherwise.  The study found that mothers who used Tylenol for fever reduction while pregnant reported greater […]

Paxil Linked To Breast Cancer

City of Hope Cancer researchers indicate that a new test called the AroER Tri-Screen, desgined to look for drug side effects that could cause cancer, found a potential link between Paxil and breast cancer.  Paxil is a widely prescribed anti depressant. Research Researchers have found that Paxil has a weak estrogen effect that could increase […]

Latest Medical Device Injury News

Report Raises Concerns Over Heart Defibrillator Leads

The Food and Drug Administration (FDA) has just announced that they received a report that a St. Jude Durata cardiac defibrillator lead conductor became externalized; meaning the wire carrying electricity from the heart defibrillator to the heart was exposed through its insulation, a potentially dangerous and life-threatening defect.

HeartSine Class 1 Defibrillator Recall

HeartSine sent out a letter to customers in September, warning that the defibrillators may intermittently turn on and off, eventually depleting the battery.

FDA Medical Device Approval Based On Little Evidence

More than half of the high-risk cardiovascular devices approved in the past decade had no supporting active control data.

St. Jude Medical Gets FDA Warning

St. Jude Medical Inc. said it received a FDA warning about manufacturing and quality-control problems at its Sylmar, California, plant.

Hospira Still Facing Manufacturing And Regulatory Issues

Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections. The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.