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Crystalens HD

  

Crystalens HD™ Videos

Reflections Pat Summerall B-Roll

GLENBROOK EYE ASSOCIATES NOW OFFERING CRYSTALENS HD™ INTRAOCULAR LENS

Newest Version of the Only FDA Approved Accommodating Lens Designed to Further Improve Near Vision

Glenbrook Eye Associates announces that it will offer a new version of the Crystalens--named Crystalens HD™--to its patients. The U.S. Food and Drug Administration (FDA) gave approval for the Crystalens HD on June 26, 2008.

The Crystalens HD is the fourth generation of the only FDA approved accommodating lens and offers improvement in near vision for many patients. The first generation Crystalens accommodating intraocular lens (IOL) was approved by the FDA in November 2003.

“Our patients have clearly indicated a preference for a high definition experience in vision correction. As a surgeon, I know well that a truly accommodating IOL helps achieve that goal. The Crystalens HD will help many of our patients experience truly good near vision without compromising on the quality of vision at intermediate or distance,” said Dr. Amy Cunningham of Glenbrook Eye Associates in Glenview, IL.

The choices in vision correction have grown significantly over the past twenty years. The development of the Crystalens HD, in particular, will give many baby boomers and seniors an opportunity to see clearly at all distances while reducing or eliminating the need for glasses. The Crystalens is the only intraocular lens that uses the natural focusing ability of the eye by using the eye muscle to flex and accommodate in order to focus on objects that are near, far or in between.

“If I were a patient having cataract surgery, I would want an IOL that projects a single point of focus and also provides a broad range of distance, intermediate and near vision. The Crystalens HD is the best available lens to achieve that goal,” said Dr. Amy Cunningham.

Glenbrook Eye Associates offers a number of vision correction options for its patient. It is important that each patient is fully informed about what to expect before, during and after a surgical procedure.

Glenbrook Eye Associates is located at 2440 Ravine Way in Glenview, IL 60025.

For more information about the Crystalens HD please visit its website at www.crystalens.com. Crystalens HD is a product developed by Bausch & Lomb www.bauschsurgical.com

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CRYSTALENS HD™ RECEIVES FDA APPROVAL

Newest Version of the Only FDA Approved Accommodating Lens Designed to Further Improve Near Vision

Aliso Viejo, Ca. June 30, 2008—Bausch & Lomb announced today that it has received approval from the Food and Drug Administration (FDA) to market the Crystalens HD™ in the United States. Crystalens accommodating intraocular lens (IOL) was first approved by the FDA in November 2003. The Crystalens HD is the fourth generation of the only FDA approved accommodating lens.

The surface of the Crystalens HD has been shaped to enhance the depth of focus with a proprietary optical modification. The enhanced optic provides an increased depth of focus which is designed to improve near vision without compromising intermediate or distance vision. The HD lens does this without inducing increased undesirable dysphotopsia or night vision symptoms.

A total of 125 primary eyes were implanted with the Crystalens HD in patients who had a visually significant cataract, less than 1 diopter of corneal astigmatism, and the potential for best corrected visual acuity (BCVA) of 20/25 or better in both eyes. Of these patients, 80% reported vision at J2 or better at four (4) months.

“Extensive market research has clearly indicated that patients and surgeons alike are asking for a truly accommodating IOL as their choice of lens. With these results, where patients reported getting one more line of near vision, we are coming ever closer to meeting the desired need for an optic that does provide truly good near vision without compromising the quality of vision at intermediate or distance,” said Michael Judy, Chief Marketing Officer at Bausch & Lomb Surgical.

Dr. John Hovanesian was a Principal Investigator in the FDA study. Dr. Hovanesian serves as Clinical Instructor at the Jules Stein Eye Institute, UCLA in California and is in private practice at Harvard Eye Associates in Laguna Hills, California.

“If I were a patient having cataract surgery, I would want an IOL that projects a single point of focus and also provides a broad range of distance, intermediate and near vision. The Crystalens HD is the best available lens to achieve that goal,” said Dr. Hovanesian. “There is no question that the HD will be my lens of choice for presbyopia correction in patients with cataracts.”

Bausch & Lomb officials said that surgeons will be instructed to continue to use the same surgical protocols for the Crystalens HD as they have used in the past. The Company has said that it will begin shipping the Crystalens HD the week of July 7th.

ABOUT CRYSTALENS HD

Crystalens HD is a product developed by Bausch & Lomb. To learn more about Crystalens HD, please visit www.crystalens.com. The Crystalens® Call Center is 1-888-393-6642.

ABOUT BAUSCH & LOMB

Bausch & Lomb is an eye health company dedicated to perfecting vision and enhancing life. Bausch & Lomb offers the world’s most comprehensive portfolio of eye health products. The Company has one of the oldest, best known and most respected healthcare brands in the world. Bausch & Lomb offers a full suite of products in cataract and vitreoretinal surgery including intraocular lenses and delivery systems, phacomulsification equipment and other surgical instruments and devices. To learn more about Bausch & Lomb, visit www.bausch.com 

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FREQUENTLY ASKED QUESTIONS ABOUT THE CRYSTALENS HD™

What is the Crystalens HD?
The Crystalens HD is an intraocular lens (IOL) that is implanted in the eye following cataract surgery. Unlike a standard cataract replacement lens, this lens is designed to mimic the natural human lens and allow the patient to focus on objects at all distances, reducing or eliminating a patient’s need for glasses.

What makes the Crystalens HD different from other IOLs?
Most IOLs are monofocal IOLs that are designed to have only one clear point of focus (usually set at distance). As a result, patients usually have to use reading glasses to see near and intermediate objects after surgery. The Crystalens HD is an accommodating IOL that has been designed to move within the eye so that most patients will be able to see at all distances without the need for glasses.

Will I still need to wear my glasses?
Most patients who have the new Crystalens HD implanted during cataract surgery are able to function at all distances including near vision without the need for glasses. However, some patients may still need the aid of reading glasses to read extremely small print or in dim light.

How long after surgery until I can see my best?
Usually most patients will see clearly within a day after cataract surgery. This good vision will continue to improve during the next few weeks. Healing time, however, may vary from patient to patient.

Is there an adjustment period after surgery?
Usually, there is not an adjustment period after surgery and good vision is attained fairly quickly. However, everyone’s eyes are different and healing times may vary from patient to patient.

Will the surgery hurt?
Most patients will experience little to no operative or post-operative pain. Typically, topical anesthetic drops are placed in the eye and oral medications are administered to help patients relax.

What are the risks of this surgery?
As with all surgical procedures, there are risks associated with cataract surgery. These risks need to be discussed thoroughly with your surgeon. Only you and your surgeon can make the decision that surgery is right for you.

What are the differences among near vision, intermediate vision and distance vision?

  • Near vision is defined as up-close vision or reading vision.
  • Intermediate vision is vision at distances from 2 to 10 feet in distance and includes activities like computer work, reading the dashboard in your car and television viewing.
  • Distance vision is looking at objects in the distance like traffic signals, watching sporting events and generally looking at any objects farther than 10 feet away.

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Crystalens HD™ Fact Sheet

Lens definition:
The Crystalens HD is an accommodating intraocular lens with an enhanced accommodative optic that provides patients the best of all worlds. The HD lens enhances the depth of focus to provide the best quantity of vision for near, distance and intermediate vision while still providing the quality of vision that patients demand.

Lens design:
The Crystalens HD is a modified plate haptic lens that uses the eye’s natural muscle to flex and accommodate in order to focus on objects at all distances.

Lens optic:
The surface has been shaped to enhance the depth of focus with an optical modification. The enhanced optic provides an increased depth of focus which is designed to improve near vision without compromising intermediate or distance vision. The HD lens does this without inducing undesirable dysphotopsia or night vision symptoms.

Intended use:
The Crystalens HD is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.

Lens parameters:
Lens optic material: silicone elastomer (Biosil™) 
Haptic material: flexible colored polyimide (Kapton™) loops are attached to each distal extremity of the biosil plates

Lens insertion:
Validated for use with either the Staar MSI-TF or the Staar MSI-PF injector in conjunction with the Staar MTFC-60c cartridge for lens insertion.

Viscoelastic use:
A cohesive viscoelastic, such as Bausch & Lomb’s Amvisc Plus, should be used for lubrication of the injector when injecting the lens.

Additional Information:
Studies have demonstrated that the improved depth of focus is continuous and that this is accomplished without a compromise to visual quality.

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