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Carl Zeiss Meditec MEL 80 Excimer Laser System - P060004

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: MEL 80 Excimer Laser System
PMA Applicant: Carl Zeiss Meditec
Address: 5160 Hacienda Drive, Dublin, CA 94568
Approval Date: August 11, 2006
Approval Letter: http://www.fda.gov/cdrh/pdf6/p060004a.pdf

What is it? The Carl Zeiss Meditec MEL 80 Excimer Laser System is an excimer laser designed for a particular type of refractive surgery called LASIK (Laser-Assisted in Situ Keratomileusis) to reduce or eliminate nearsightedness and astigmatism.

How does it work? An excimer laser is a machine that makes and aims a strong beam of ultraviolet (UV) light. The machine creates a brief, intense pulse that lasts just a few billionths of a second. Each pulse removes a tiny amount of tissue from the surface of the cornea. The effect of many such pulses is to flatten the central cornea at certain locations in order to treat nearsightedness and/or astigmatism.

When is it used? The MEL 80 Excimer Laser is intended for use in the LASIK treatments of patients who:

• have near-sightedness of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D
• have a maximum manifest refraction spherical equivalent (MRSE) of -7.00 D
• are 21 years of age or older with documentation of stable manifest refraction over the past year as shown by change in sphere and cylinder of ≤ 0.5 D

What will it accomplish? Eximer laser treatment is intended to reduce or eliminate near-sightedness and astigmatism.
However, LASIK surgery carries certain risks.

• Sometimes LASIK does not give you the best vision the first time. To get the best vision, you may need to have LASIK surgery again.
• Sometimes LASIK leaves your vision worse than before, even with glasses or contacts.
• After LASIK, you may need to wear glasses or contacts to see clearly up close, even if you did not need to wear them before.
• LASIK can give you vision problems or symptoms that you did not have before, and it can cause vision problems or symptoms that you had before to become worse (e.g., dry eye, halos, glare).

When should it not be used? You should NOT have LASIK if any of the things below apply. In these cases, the risk is greater than the benefit.

• You have a disease that makes your body less able to heal. These include collagen vascular (e.g., rheumatoid arthritis), autoimmune (e.g., lupus), or immunodeficiency diseases (e.g., AIDS).
• You are pregnant or nursing, which can cause short-term changes in your cornea. Such changes cannot be predicted. In such cases, LASIK might change the shape of your cornea in a way that would harm your vision.
• You show signs of a condition that causes a thinning of your cornea, such as Keratoconus. Cornea thinning can lead to serious problems during and after LASIK. It may result in poor vision after LASIK. You may need additional surgery.
• You are taking medicines that have side effects on your eyes. Such medicines include: Accutane¹ to treat acne and Cordarone² to normalize heart rhythm. These drugs may affect the accuracy of LASIK or the way the cornea heals after LASIK. LASIK surgery may cause poor vision.

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf6/p060004.html

Other:

• General information about LASIK can be found at the “LASIK Eye Surgery” website maintained by the FDA: http://www.fda.gov/cdrh/lasik/
• Tips on what to expect from LASIK surgery from the Federal Trade Commission: http://www.ftc.gov/bcp/conline/pubs/health/lasik.htm
• A patient education tutorial on LASIK surgery from the National Institutes of Health: http://www.nlm.nih.gov/medlineplus/tutorials/lasik.html

¹ Accutane (isotretinoin) is the registered trademark of Hoffman La Roche Inc.
² Cordarone (amiodarone hydrochloride) is the registered trademark of Sanofi-Synthlabo.

Updated September 25, 2006

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