FDA Approves Bausch & Lomb Technolas® 217z Zyoptix™ System For Personalized Vision Correction,
The World’s Leading System for Custom Laser Eye Surgery, For Use in United States


FOR RELEASE FRIDAY, OCTOBER 10, 2003

ROCHESTER, N.Y. – Bausch & Lomb (NYSE:BOL) has received approval from the U.S. Food and Drug Administration for its patented, advanced laser eye surgery system – the Bausch & Lomb Technolas® 217z Zyoptix™ System for Personalized Vision Correction – now making the world’s leading technology for custom laser eye surgery available in the United States.

Since 2001, surgeons have used the Zyoptix system, available throughout Europe, Asia, Latin America and Canada, to successfully perform approximately 100,000 personalized LASIK procedure

“Zyoptix is the most sophisticated ocular measuring system available. It has been used world wide in over 100.000 laser eye surgeries, and provides the surgeon with the greatest understanding of each person’s unique causes for blurred vision (known as aberrations), and a customized plan for correcting these refractive errors. Many patients report seeing more vividly and clearly than they had with glasses or contact lenses, and in a number of cases, are able to see significantly better than 20/20 (normal vision). This wave front technology is our most important advance in (LASIK) laser surgery, as it allows us to directly enter these highly accurate measurements into the laser’s computer, giving patients access to the most accurate correction possible. Of the three FDA approved wave front measuring devices, the Bausch and Lomb Zywave has the greatest world wide experience and acceptance, the largest range of FDA approved prescription correction (so that most patients can utilize this technology), and enjoys the best outcomes and success in several published studies.” said Steven M. Silverstein. M.D., of Kansas City

The Zyoptix system has the widest treatment range of any custom laser eye system available in the United States. Zyoptix LASIK surgery can correct up to -7.00 diopters of nearsightedness (myopia) with up to -3.00 diopters of astigmatism and “manifest refraction spherical equivalent” equal to or less than -7.50D. MRSE is a measurement that describes the total refractive error of the eye.

Designed to provide truly personalized laser vision correction, the Zyoptix platform combines an upgraded Bausch & Lomb Technolas 217 excimer laser with the advanced diagnostics of the Zyoptix Diagnostic Workstation unit and Zylink™ treatment software.

The Zyoptix system allows the surgeon to create a precise map of both the inside and the outside surfaces each patient’s cornea, and using wavefront technology, gives the surgeon the ability to measure the unique imperfections within each patient’s optical system. These imperfections include higher-order aberrations, detectable in low-light conditions like driving at night, and contribute to visual disturbances such as reduced contrast sensitivity, glare or halos. Higher-order aberrations are correctable only through wavefront-guided customized laser vision correction like that offered by the Zyoptix system.

Silverstein Eye Centers is very proud to provide Zyoptix customized LASIK for patients, and is one of only a few practices in this region of the country to own this system.

Clinical trial results are based on a cohort of 340 eyes with a combination of myopia and astigmatism. Highlights include:

After surgery with the Zyoptix system:

  • 91.5% of patients had unaided 20/20 vision or better (Uncorrected Visual Acuity);
  • 70.3% of patients had unaided 20/16 vision.
  • More than 94% of subjects maintained or improved from their best-corrected vision six months post-operatively. *Six months after surgery with the Zyoptix system:
  • 99.0% of subjects reported that they were satisfied with the results;
  • 99.7% indicated improvement in quality of vision, of which more than 40% reported improvement in night vision while driving.
  • No patients reported dissatisfaction with their outcomes.

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Notes to reporters and editors:

For interviews with Dr. Steven Silverstein, call his office at 816-358-3600

Multimedia Available:

RADIO ANR: An audio news release is available today on Audioline, AP Radio and Westwood One Radio. For more information call Tim Doyle at 414-321-6210.

TV VNR: The video news release about the Zyoptix system will be fed today, October 10, from 1:00 pm – 1:30 pm ET on Telstar 6, Transponder 15 (C-Band), Downlink Frequency: 4000 (V), Audio: 6.2 & 6.8 MHz. For hard copy requests, contact Harbour Media Relations at 518-583- 9982 ext. 10. For technical information, today only call 917-992-0920. The VNR also is available on www.newstream.com.

Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Celebrating its 150th anniversary in 2003, the Company is headquartered in Rochester, New York. Bausch & Lomb’s 2002 revenues were $1.8 billion; it employs approximately 11,500 people worldwide and its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Web site at www.bausch.com. Copyright Bausch & Lomb.

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