Insure Lasik Safety With Better Reporting

Mike Bryant
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Posted by Mike BryantOctober 19, 2009 3:35 PM

Lasik is a procedure that has benifited thousands of Americans They have regained the ability to see better without the aid of glasses. Many have seen it as a miracle. But, as with other procedures, there have been problems. Considering the procedure affect your vision, the most important of your five senses, even small errors can lead to major problems.

The U.S. Food and Drug Administration is conducting a study to find the percentage of patients who experience serious quality-of-life problems after Lasik eye surgery. After a brief look at the topic, they have issued warning letters to a number of Lasik facilities that weren't properly reporting problems with the procedure.

This past month, the FDA sent warning letters to 17 Lasik ambulatory surgical centers because they each were suspected of having inadequate systems for reporting specific problems suffered by patients.

"Many people in the U.S. undergo Lasik procedures. Ambulatory surgical centers that perform Lasik must maintain a robust reporting system as required by law," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said in the news release. "Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in Lasik procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

As part of their release the FDA provided the additional advice:

Things to think about ...
  • Find the right doctor. (see below)

  • Cost --Most medical insurance will not pay for this surgery

  • LASIK won't work well if your sight changes often. Have you needed a change in your contact lenses or glasses in the past year? Vision changes are more likely if you are:

    • In your early 20s
    • Diabetic or have certain other diseases
    • Pregnant or breast-feeding
    • Taking medicines that cause vision changes, such as steroids
  • Laser eye surgery is not a good choice for people who do contact sports. Examples: boxing, wrestling, martial arts

  • Laser surgery is not approved for anyone under age 18.

  • Some jobs do not allow workers to have certain kinds of eye surgery. Check with your boss to make sure.

Things Your Doctor Must Look for Before Surgery

Your doctor needs to find out if you have any of these conditions:

  • Past or current eye diseases, such as glaucoma and ocular hypertension.

  • Eye injuries or other laser eye surgery.

  • Large pupils, thin corneas, or dry eyes.

Finding the Right Doctor is Very Important

Ask these questions before choosing a doctor:

  • Experience: How many LASIK eye surgeries has this doctor done with the same laser?

  • Equipment: Does this doctor use an FDA-approved laser?

  • Information: Does this doctor take the time to answer all your questions? Do you feel at ease giving and getting information with this doctor?

If You Choose LASIK Before surgery:
  • Your doctor should give you an informed consent form. Read and understand it. Get answers to all your questions.

  • Have a detailed eye exam.

  • Plan not to drive or work right after the surgery.

After surgery:
  • Take at least two days off work to rest and get better.

  • You will have some pain for a few days.

  • You will not be able to see clearly for a few days. Final results could take months.

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