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Consumer Information on: MEL 80? Excimer Laser System - P060004S001

Mon, 04/25/2011 - 8:31am
U.S. Food & Drug Administration

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Picture of the system.

Product Name: MEL 80™ Excimer Laser System

PMA Applicant: Carl Zeiss Meditec Inc.

Address: 5160 Hacienda Drive, Dublin, CA 94568

Approval Date: March 28, 2011

Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf6/p060004s001a.pdf

What is it? The Carl Zeiss Meditec MEL 80™ Excimer Laser System is a refractive excimer laser designed for a particular type of surgery called LASIK (laser-assisted in situ keratomileusis) to change how the eye bends light (refractive surgery). The laser system uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue from the eye according to the patient’s treatment plan and uses an eyetracker that detects the position of the eye and aligns the laser pulse with the cornea.

How does it work? The laser system treats farsightedness by removing tissue from the outer edge of the cornea to steepen it and treats astigmatism by steepening the central cornea by different amounts at different orientations to correct for uneven focus.

When is it used? The device is indicated for use in primary LASIK treatments for the reduction or elimination of naturally-occurring farsightedness in patients who:

  • have less than or equal to +5.0 diopter (D) with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D.
  • have a maximum manifest refraction spherical equivalent (MRSE) (that is, the average refractive power in diopters needed to correct the refractive error of the eye) of +5.0 D.
  • are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of less than or equal to 0.5.D.

What will it accomplish? In the clinical study, doctors performed LASIK treatment in each eye with the MEL 80™. Then they measured the vision of each eye without glasses after 1, 3, 6, 9, and 12 months. After 3, 6, 9, and 12 months, more than 59% (93 out of 158) of eyes had 20/20 vision or better. More than 96% (153 out of 158) had 20/40 vision or better.

However, LASIK surgery carries certain risks.

  • Sometimes LASIK does not give you the outcome you want.
  • LASIK can sometimes leave 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.
  • LASIK can cause prior existing vision problems or symptoms to become worse (such as, dry eye, halos, glare, difficulty with night driving, ghost images, and fluctuating vision).

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

  • Patients with severe dry eye
  • Patients with active corneal infection or inflammation
  • Patients with advanced glaucoma
  • Patients with a cornea too thin to perform LASIK without increasing the risk of causing a bulging cornea (ectasia)
  • Patients with active connective tissue diseases or autoimmune diseases which have been associated with corneal melting such as rheumatoid arthritis, Wegener’s granulomatosis, relapsing polychondritis, and polyarteritis nodosa
  • Pregnant or nursing women
  • Patients with signs of keratoconus (thinning and cone-shaped bulging of the cornea) or pellucid marginal degeneration (thinning of the lower outer edge of the cornea where adjacent cornea may protrude)
  • Patients with active, uncontrolled diabetes mellitus or visually significant diabetic complications
  • Patients with recent herpes eye infection (simplex or zoster) or significant corneal damage (poor sensation, scarring, blood vessels growing into the cornea)) from past herpes infection
  • Patients with a significantly weakened immune system due to medication (such as high dose steroids) or disease (such as AIDS)

Additional information : Summary of Safety and Effectiveness and labeling are available online.

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