EYE » Topics » Cataract Surgery

These excerpts taken from the EYE 10-K filed Feb 24, 2009.

Cataract Surgery

We focus on the four key devices for the cataract surgery market:

 

   

Monofocal foldable IOLs — Monofocal foldable IOLs are artificial lenses used to replace the human lens.

 

   

Implantation systems — Implantation systems are designed and used specifically to implant IOLs during cataract surgery.

 

   

Phacoemulsification systems — Phacoemulsification systems use ultrasound during small incision cataract surgery to break apart and remove the cloudy human lens prior to its replacement with an IOL.

 

   

Viscoelastics — Viscoelastics provide a barrier of protection for the cornea during phacoemulsification and maintain the shape of the eye during IOL insertion.

Monofocal Intraocular Lenses. As a leading provider of IOLs, we offer surgeons a choice of high quality, innovative foldable IOLs in both acrylic and silicone materials, together with our proprietary implantation systems, for use in minimally invasive cataract surgical procedures. Sales of our monofocal IOLs represented approximately 24% of our net sales in each of 2008, 2007 and 2006. Our monofocal IOLs primarily include:

 

   

Tecnis — a family of foldable IOLs with an aspheric surface. The Tecnis lens is the first IOL to receive FDA approval for claims of improved functional vision, which can result in quicker recognition of objects in lower-light conditions. The Tecnis lens was the first aspheric lens designated as a “new technology intraocular lens” by the U.S. Center for Medicare and Medicaid Services (“CMS”) (formerly the Health Care Financing Administration). With this designation, ambulatory surgery centers can receive $50 in additional reimbursement when implanting the Tecnis IOL. The three-piece Tecnis lens is available globally in acrylic and silicone. The new Tecnis 1-piece IOL combines the Tecnis aspheric optic with proprietary advances in 1-piece IOL design and is available in the U.S. and Europe in an acrylic material.

 

   

Sensar — an acrylic monofocal IOL, with the patented OptiEdge design, intended to reduce lens epithelial cell migration, in order to lessen the need for subsequent corrective laser procedures, and to reduce the potential for unwanted glare and reflections following implantation.

 

   

ClariFlex — a silicone monofocal IOL, also with the OptiEdge design.

Implantation Systems. As a companion to our foldable IOLs, we market insertion systems for each of our foldable IOL models. The Unfolder, our proprietary series of implantation systems, which includes the Emerald, Emerald AR and SilverT implantation systems, is used for insertion of our foldable IOLs. These systems assist the surgeon in achieving controlled release of the intraocular lens into the capsular bag through a small incision in the eye.

Phacoemulsification Systems. We are a leading provider of phacoemulsification systems, and have a range of systems to meet market needs. Phacoemulsification systems use disposable or reusable packs that are necessary to operate the equipment. The majority of our phacoemulsification product sales are from sales of these packs and related accessories.

We currently market the following phacoemulsification systems:

 

   

WhiteStar Signature — the WhiteStar Signature system is our premium system and our newest to the market. The WhiteStar Signature system combines the proven performance of proprietary WhiteStar technology, which creates less heat and turbulence in the ocular environment, with the safety of advanced Fusion fluidics to optimize patient outcomes.

 

   

Sovereign Compact — is a mid-sized phacoemulsification system designed to meet surgeons’ needs for an advanced phacoemulsification system, with the similar functionality of the WhiteStar Signature system, in a smaller, more portable size. The Sovereign Compact system is also available with Occlusion Mode, our proprietary fluidics system, and WhiteStar technology.

 

6


Table of Contents
   

Diplomax II — is a small-sized phacoemulsification system designed for surgeons who need a less expensive and more portable machine. These systems do not include WhiteStar technology, but do employ Occlusion Mode technology.

Viscoelastics. We are a leading provider of viscoelastic products with the Healon family of viscoelastics. The different characteristics associated with each Healon product, Healon, Healon GV, Healon5 and Healon D, provide surgeons with a range of viscoelastic choices that combine the familiarity of the Healon line with advanced technologies to satisfy different surgical needs. In 2008, we introduced dual combination viscoelastic packs featuring dispersive and cohesive Healon products. Sales of our viscoelastic products represented approximately 11% of our net sales in both 2008 and 2007, and 12% of our net sales in 2006.

Other Cataract Surgical Related Products. In addition to our IOLs, phacoemulsification equipment and viscoelastics, we also provide several ancillary products related to the cataract surgery market, including:

 

   

Irrigating Solutions. We offer irrigating solutions for use in cataract surgery to help maintain space in the eye and to aid in removing residual tissue during phacoemulsification. Irrigating solutions are balanced saline solutions that are compatible with the natural fluid of the anterior segment of the eye.

 

   

Custom Eye Trays. We work with partners in our local markets to offer custom eye trays to our customers. These custom eye trays typically consist of all of the ancillary items that a surgeon needs to use in a single cataract surgery, such as surgical knives, drapes, gloves and gowns. Our partners typically handle assembly, distribution and billing for the product and in most cases we receive a fee per tray from our partners.

 

   

Capsular Tension Rings. We also sell capsular tension rings, which are inserted into the capsular bag during cataract surgery and function to stabilize the capsular bag during placement of an IOL.

Cataract Surgery

FACE="Times New Roman" SIZE="2">We focus on the four key devices for the cataract surgery market:

 







  

Monofocal foldable IOLs — Monofocal foldable IOLs are artificial lenses used to replace the human lens.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Implantation systems — Implantation systems are designed and used specifically to implant IOLs during cataract surgery.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Phacoemulsification systems — Phacoemulsification systems use ultrasound during small incision cataract surgery to break apart and remove the cloudy
human lens prior to its replacement with an IOL.

 







  

Viscoelastics — Viscoelastics provide a barrier of protection for the cornea during phacoemulsification and maintain the shape of the eye during IOL
insertion.

Monofocal Intraocular Lenses. As a leading provider of IOLs, we offer surgeons a choice of high
quality, innovative foldable IOLs in both acrylic and silicone materials, together with our proprietary implantation systems, for use in minimally invasive cataract surgical procedures. Sales of our monofocal IOLs represented approximately 24% of
our net sales in each of 2008, 2007 and 2006. Our monofocal IOLs primarily include:

 







  

Tecnis — a family of foldable IOLs with an aspheric surface. The Tecnis lens is the first IOL to receive FDA approval for claims of improved
functional vision, which can result in quicker recognition of objects in lower-light conditions. The Tecnis lens was the first aspheric lens designated as a “new technology intraocular lens” by the U.S. Center for Medicare and
Medicaid Services (“CMS”) (formerly the Health Care Financing Administration). With this designation, ambulatory surgery centers can receive $50 in additional reimbursement when implanting the Tecnis IOL. The three-piece
Tecnis lens is available globally in acrylic and silicone. The new Tecnis 1-piece IOL combines the Tecnis aspheric optic with proprietary advances in 1-piece IOL design and is available in the U.S. and Europe in an acrylic
material.

 







  

Sensar — an acrylic monofocal IOL, with the patented OptiEdge design, intended to reduce lens epithelial cell migration, in order to lessen the
need for subsequent corrective laser procedures, and to reduce the potential for unwanted glare and reflections following implantation.

 







  

ClariFlex — a silicone monofocal IOL, also with the OptiEdge design.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Implantation Systems. As a companion to our foldable IOLs, we market insertion systems for each of our foldable IOL models. The Unfolder,
our proprietary series of implantation systems, which includes the Emerald, Emerald AR and SilverT implantation systems, is used for insertion of our foldable IOLs. These systems assist the surgeon in achieving controlled
release of the intraocular lens into the capsular bag through a small incision in the eye.

Phacoemulsification Systems. We are a
leading provider of phacoemulsification systems, and have a range of systems to meet market needs. Phacoemulsification systems use disposable or reusable packs that are necessary to operate the equipment. The majority of our phacoemulsification
product sales are from sales of these packs and related accessories.

We currently market the following phacoemulsification systems:

 







  

WhiteStar Signature — the WhiteStar Signature system is our premium system and our newest to the market. The WhiteStar Signature
system combines the proven performance of proprietary WhiteStar technology, which creates less heat and turbulence in the ocular environment, with the safety of advanced Fusion fluidics to optimize patient outcomes.

 







  

Sovereign Compact — is a mid-sized phacoemulsification system designed to meet surgeons’ needs for an advanced phacoemulsification system, with the
similar functionality of the WhiteStar Signature system, in a smaller, more portable size. The Sovereign Compact system is also available with Occlusion Mode, our proprietary fluidics system, and WhiteStar technology.

 


6







Table of Contents








  

Diplomax II — is a small-sized phacoemulsification system designed for surgeons who need a less expensive and more portable machine. These
systems do not include WhiteStar technology, but do employ Occlusion Mode technology.

SIZE="2">Viscoelastics. We are a leading provider of viscoelastic products with the Healon family of viscoelastics. The different characteristics associated with each Healon product, Healon, Healon GV, Healon5 and
Healon D,
provide surgeons with a range of viscoelastic choices that combine the familiarity of the Healon line with advanced technologies to satisfy different surgical needs. In 2008, we introduced dual combination viscoelastic packs
featuring dispersive and cohesive Healon products. Sales of our viscoelastic products represented approximately 11% of our net sales in both 2008 and 2007, and 12% of our net sales in 2006.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Other Cataract Surgical Related Products. In addition to our IOLs, phacoemulsification equipment and viscoelastics, we also provide several
ancillary products related to the cataract surgery market, including:

 







  

Irrigating Solutions. We offer irrigating solutions for use in cataract surgery to help maintain space in the eye and to aid in removing residual tissue
during phacoemulsification. Irrigating solutions are balanced saline solutions that are compatible with the natural fluid of the anterior segment of the eye.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Custom Eye Trays. We work with partners in our local markets to offer custom eye trays to our customers. These custom eye trays typically consist of all of
the ancillary items that a surgeon needs to use in a single cataract surgery, such as surgical knives, drapes, gloves and gowns. Our partners typically handle assembly, distribution and billing for the product and in most cases we receive a fee per
tray from our partners.

 







  

Capsular Tension Rings. We also sell capsular tension rings, which are inserted into the capsular bag during cataract surgery and function to stabilize the
capsular bag during placement of an IOL.

Cataract Surgery

FACE="Times New Roman" SIZE="2">We focus on the four key devices for the cataract surgery market:

 







  

Monofocal foldable IOLs — Monofocal foldable IOLs are artificial lenses used to replace the human lens.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Implantation systems — Implantation systems are designed and used specifically to implant IOLs during cataract surgery.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Phacoemulsification systems — Phacoemulsification systems use ultrasound during small incision cataract surgery to break apart and remove the cloudy
human lens prior to its replacement with an IOL.

 







  

Viscoelastics — Viscoelastics provide a barrier of protection for the cornea during phacoemulsification and maintain the shape of the eye during IOL
insertion.

Monofocal Intraocular Lenses. As a leading provider of IOLs, we offer surgeons a choice of high
quality, innovative foldable IOLs in both acrylic and silicone materials, together with our proprietary implantation systems, for use in minimally invasive cataract surgical procedures. Sales of our monofocal IOLs represented approximately 24% of
our net sales in each of 2008, 2007 and 2006. Our monofocal IOLs primarily include:

 







  

Tecnis — a family of foldable IOLs with an aspheric surface. The Tecnis lens is the first IOL to receive FDA approval for claims of improved
functional vision, which can result in quicker recognition of objects in lower-light conditions. The Tecnis lens was the first aspheric lens designated as a “new technology intraocular lens” by the U.S. Center for Medicare and
Medicaid Services (“CMS”) (formerly the Health Care Financing Administration). With this designation, ambulatory surgery centers can receive $50 in additional reimbursement when implanting the Tecnis IOL. The three-piece
Tecnis lens is available globally in acrylic and silicone. The new Tecnis 1-piece IOL combines the Tecnis aspheric optic with proprietary advances in 1-piece IOL design and is available in the U.S. and Europe in an acrylic
material.

 







  

Sensar — an acrylic monofocal IOL, with the patented OptiEdge design, intended to reduce lens epithelial cell migration, in order to lessen the
need for subsequent corrective laser procedures, and to reduce the potential for unwanted glare and reflections following implantation.

 







  

ClariFlex — a silicone monofocal IOL, also with the OptiEdge design.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Implantation Systems. As a companion to our foldable IOLs, we market insertion systems for each of our foldable IOL models. The Unfolder,
our proprietary series of implantation systems, which includes the Emerald, Emerald AR and SilverT implantation systems, is used for insertion of our foldable IOLs. These systems assist the surgeon in achieving controlled
release of the intraocular lens into the capsular bag through a small incision in the eye.

Phacoemulsification Systems. We are a
leading provider of phacoemulsification systems, and have a range of systems to meet market needs. Phacoemulsification systems use disposable or reusable packs that are necessary to operate the equipment. The majority of our phacoemulsification
product sales are from sales of these packs and related accessories.

We currently market the following phacoemulsification systems:

 







  

WhiteStar Signature — the WhiteStar Signature system is our premium system and our newest to the market. The WhiteStar Signature
system combines the proven performance of proprietary WhiteStar technology, which creates less heat and turbulence in the ocular environment, with the safety of advanced Fusion fluidics to optimize patient outcomes.

 







  

Sovereign Compact — is a mid-sized phacoemulsification system designed to meet surgeons’ needs for an advanced phacoemulsification system, with the
similar functionality of the WhiteStar Signature system, in a smaller, more portable size. The Sovereign Compact system is also available with Occlusion Mode, our proprietary fluidics system, and WhiteStar technology.

 


6







Table of Contents








  

Diplomax II — is a small-sized phacoemulsification system designed for surgeons who need a less expensive and more portable machine. These
systems do not include WhiteStar technology, but do employ Occlusion Mode technology.

SIZE="2">Viscoelastics. We are a leading provider of viscoelastic products with the Healon family of viscoelastics. The different characteristics associated with each Healon product, Healon, Healon GV, Healon5 and
Healon D,
provide surgeons with a range of viscoelastic choices that combine the familiarity of the Healon line with advanced technologies to satisfy different surgical needs. In 2008, we introduced dual combination viscoelastic packs
featuring dispersive and cohesive Healon products. Sales of our viscoelastic products represented approximately 11% of our net sales in both 2008 and 2007, and 12% of our net sales in 2006.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Other Cataract Surgical Related Products. In addition to our IOLs, phacoemulsification equipment and viscoelastics, we also provide several
ancillary products related to the cataract surgery market, including:

 







  

Irrigating Solutions. We offer irrigating solutions for use in cataract surgery to help maintain space in the eye and to aid in removing residual tissue
during phacoemulsification. Irrigating solutions are balanced saline solutions that are compatible with the natural fluid of the anterior segment of the eye.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Custom Eye Trays. We work with partners in our local markets to offer custom eye trays to our customers. These custom eye trays typically consist of all of
the ancillary items that a surgeon needs to use in a single cataract surgery, such as surgical knives, drapes, gloves and gowns. Our partners typically handle assembly, distribution and billing for the product and in most cases we receive a fee per
tray from our partners.

 







  

Capsular Tension Rings. We also sell capsular tension rings, which are inserted into the capsular bag during cataract surgery and function to stabilize the
capsular bag during placement of an IOL.

These excerpts taken from the EYE 10-K filed Mar 3, 2008.

Cataract Surgery

We focus on the four key devices for the cataract surgery market:

 

   

Foldable IOLs — Foldable IOLs are artificial lenses used to replace the human lens.

 

   

Implantation systems — Implantation systems are designed and used specifically to implant IOLs during cataract surgery.

 

   

Phacoemulsification systems — Phacoemulsification systems use ultrasound during small incision cataract surgery to break apart and remove the cloudy human lens prior to its replacement with an IOL.

 

   

Viscoelastics — Viscoelastics provide a barrier of protection for the cornea during phacoemulsification and maintain the shape of the eye during IOL insertion.

 

5


Table of Contents

Intraocular Lenses. As a leading provider of IOLs, we offer surgeons a choice of high quality, innovative foldable IOLs in both acrylic and silicone materials, together with our proprietary implantation systems, for use in minimally invasive cataract surgical procedures. We offer a selection of IOLs in both monofocal and multifocal designs. Sales of our IOLs represented approximately 29% of our net sales in 2007 and 2006, respectively, and 28% of our net sales in 2005. Our IOLs primarily include:

Cataract Surgery

SIZE="2">We focus on the four key devices for the cataract surgery market:

 







  

Foldable IOLs — Foldable IOLs are artificial lenses used to replace the human lens.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Implantation systems — Implantation systems are designed and used specifically to implant IOLs during cataract surgery.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Phacoemulsification systems — Phacoemulsification systems use ultrasound during small incision cataract surgery to break apart and remove the cloudy
human lens prior to its replacement with an IOL.

 







  

Viscoelastics — Viscoelastics provide a barrier of protection for the cornea during phacoemulsification and maintain the shape of the eye during IOL
insertion.

 


5







Table of Contents


Intraocular Lenses. As a leading provider of IOLs, we offer surgeons a choice of high quality,
innovative foldable IOLs in both acrylic and silicone materials, together with our proprietary implantation systems, for use in minimally invasive cataract surgical procedures. We offer a selection of IOLs in both monofocal and multifocal designs.
Sales of our IOLs represented approximately 29% of our net sales in 2007 and 2006, respectively, and 28% of our net sales in 2005. Our IOLs primarily include:

FACE="Times New Roman" SIZE="2">Monofocal Lenses

 







  

Tecnis — a family of foldable IOLs with an aspheric surface. The Tecnis lens is the first and the only IOL to receive FDA approval for claims of
improved functional vision, which results in quicker recognition of objects in lower-light conditions. The Tecnis lens was the first aspheric lens designated as a “new technology intraocular lens” by the U.S. Center for
Medicare and Medicaid Services (CMS). With this designation, ambulatory surgery centers can receive $50 in additional reimbursement when implanting the Tecnis IOL. The three-piece Tecnis lens is available globally in acrylic
and silicone. The new Tecnis 1-piece IOL combines the Tecnis aspheric optic with proprietary advances in 1-piece IOL design and is available in the U.S. and Europe in an acrylic material.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Sensar — an acrylic monofocal IOL, with the patented OptiEdge design, intended to reduce post-surgical posterior capsular opacification, in order
to lessen the need for subsequent corrective laser procedures, and to reduce the potential for unwanted glare and reflections following implantation.

 







  

ClariFlex — a silicone monofocal IOL, also with the OptiEdge design.

STYLE="margin-top:18px;margin-bottom:0px; text-indent:4%">Multifocal and Refractive Lenses

 







  

ReZoom — an acrylic multifocal IOL with optical zones that provide near, intermediate and distance vision, reducing that patient’s dependence on
eyeglasses. This lens received approval from CMS to allow patients in the U.S. to pay the difference between the $150 reimbursement rate for IOLs and the amount that is charged. The ReZoom IOL is also approved in Europe for the treatment
of presbyopia.

 







  

Tecnis Multifocal — a multifocal IOL, available in both silicone and acrylic, with a diffractive, aspheric lens surface is approved in Europe, Latin
America and Asia Pacific for treatment of presbyopia.

 







  

Verisyse — a phakic IOL that works in conjunction with the human lens to treat high myopia.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

VeriFlex — a foldable version of the Verisyse; a phakic IOL that works in conjunction with the human lens to treat high myopia, currently available
outside of the U.S.

Implantation Systems. As a companion to our foldable IOLs, we market insertion systems for
each of our foldable IOL models. The Unfolder, our proprietary series of implantation systems, which includes the Emerald, Emerald AR and SilverT implantation systems, is used for insertion of our foldable IOLs. These
systems assist the surgeon in achieving controlled release of the intraocular lens into the capsular bag through a small incision in the eye.

SIZE="2">Phacoemulsification Systems. We are a leading provider of phacoemulsification systems, and have a range of systems to meet market needs. Phacoemulsification systems use disposable or reusable packs that are necessary to
operate the equipment. The majority of our phacoemulsification product sales are from sales of these packs and related accessories.

SIZE="2">We currently market the following phacoemulsification systems:

 







  

WhiteStar Signature — the WhiteStar Signature system is our premium system and our newest to the market, launched in 2007. The WhiteStar
Signature
system combines the proven performance of proprietary WhiteStar technology, which creates less heat and turbulence in the ocular environment, with the safety of advanced Fusion fluidics to optimize patient
outcomes.

 







  

Sovereign Compact — is a mid-sized phacoemulsification system designed to meet surgeons’ needs for an advanced phacoemulsification system, with the
similar functionality of the WhiteStar Signature system, in a smaller, more portable size. The Sovereign Compact system is also available with Occlusion Mode, our proprietary fluidics system, and WhiteStar technology.

 


6







Table of Contents








  

Diplomax II — is a small-sized phacoemulsification system designed for surgeons who need a less expensive and more portable machine. These
systems do not include WhiteStar technology, but do employ Occlusion Mode technology.

SIZE="2">Viscoelastics. We are a leading provider of viscoelastic products with the Healon family of viscoelastics. The different characteristics associated with each Healon product, Healon, Healon GV and
Healon5,
provide surgeons with a range of viscoelastic choices that combine the familiarity of the Healon line with advanced technologies to satisfy different surgical needs. Healon was the first viscoelastic introduced into the
ophthalmic surgical product market and is known for its purity and ease of use. Healon GV is of a greater viscosity than the original Healon solution. Healon5 is the first viscoadaptive agent to exhibit properties of both
cohesive and dispersive viscoelastics and has the highest viscosity. Sales of our viscoelastic products represented approximately 11%, 12% and 14% of our net sales in 2007, 2006 and 2005, respectively.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Other Cataract Surgical Related Products. In addition to our IOLs, phacoemulsification equipment and viscoelastics, we also provide several
ancillary products related to the cataract surgery market, including:

 







  

Irrigating Solutions. We offer irrigating solutions for use in cataract surgery to help maintain space in the eye and to aid in removing residual tissue
during phacoemulsification. Irrigating solutions are balanced saline solutions that are compatible with the natural fluid of the anterior segment of the eye.

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

Custom Eye Trays. We work with partners in our local markets to offer custom eye trays to our customers. These custom eye trays typically consist of all of
the ancillary items that a surgeon needs to use in a single cataract surgery, such as surgical knives, drapes, gloves and gowns. Our partners typically handle assembly, distribution and billing for the product and in most cases we receive a fee per
tray from our partners.

 







  

Capsular Tension Rings. We also sell capsular tension rings, which are inserted into the capsular bag during cataract surgery and function to stabilize the
capsular bag during placement of an IOL.

This excerpt taken from the EYE 10-K filed Mar 1, 2007.

Cataract Surgery

We focus on the four key devices for the cataract surgery market:

·                  Foldable IOLs — Foldable IOLs are artificial lenses used to replace the human lens.

·                  Implantation systems — Implantation systems are designed and used specifically to implant IOLs during cataract surgery.

·                  Phacoemulsification systems — Phacoemulsification systems use ultrasound during small incision cataract surgery to break apart and remove the cloudy human lens prior to its replacement with an IOL.

·                  Viscoelastics — Viscoelastics provide a barrier of protection for the cornea during phacoemulsification and maintain the shape of the eye during IOL insertion.

This excerpt taken from the EYE 10-K filed Mar 2, 2005.

Cataract Surgery

 

We focus on the four key devices for the cataract surgery market:

 

    Foldable IOLs – Foldable IOLs are artificial lenses used to replace the human lens.

 

    Implantation systems – Implantation systems are designed and used specifically to implant IOLs during cataract surgery.

 

    Phacoemulsification systems – Phacoemulsification systems use ultrasound during small incision cataract surgery to break apart and remove the cloudy human lens prior to its replacement with an IOL.

 

    Viscoelastics – Viscoelastics provide a barrier of protection for the cornea during phacoemulsification and maintain the shape of the eye during IOL insertion.

 

Intraocular Lenses. As a leading provider of IOLs, we offer surgeons a choice of high quality, innovative foldable IOLs in both acrylic and silicone, together with our proprietary implantation systems, for use in minimally invasive cataract surgical procedures. We are the only company that offers a selection of IOLs in both silicone and acrylic materials in the United States, and we offer both monofocal and multifocal designs. Sales of our IOLs represented approximately 32%, 34% and 34% of our net sales in 2004, 2003 and 2002, respectively. Our IOLs include:

 

    Tecnis – the only foldable IOL with an aspheric surface and the only IOL to receive FDA approval for claims of improved functional vision, which results in quicker recognition of objects in lower-light conditions. Tecnis Multifocal is approved in Europe for treatment of presbyopia. We acquired this product from Pfizer in June 2004.

 

    Sensar – an acrylic monofocal IOL, with the patented OptiEdge design, intended to reduce post-surgical posterior capsular opacification, in order to lessen the need for subsequent corrective laser procedures, and to reduce the potential for unwanted glare and reflections following implantation.

 

    ClariFlex – a silicone monofocal IOL, also with the OptiEdge design.

 

    PhacoFlex II – a line of silicone monofocal IOLs.

 

    Array, Array II and ReZoom – a silicone or acrylic multifocal IOL with optical zones that provide near, intermediate and distance vision, reducing that patient’s dependence on eyeglasses. The Array and ReZoom IOLs are also approved in Europe for the treatment of presbyopia.

 

    CeeOn – a brand of IOL that is available in both a foldable and PMMA, or non-foldable, version. We also acquired this product from Pfizer.

 

Implantation Systems. As a companion to our foldable IOLs, we market insertion systems for each of our foldable IOL models. The Unfolder, our proprietary series of implantation systems, which includes the Emerald, SilverT and Silver implantation systems, is used for insertion of our foldable IOLs. These systems assist the surgeon in achieving controlled release of the intraocular lens into the capsular bag through a small incision in the eye.

 

Phacoemulsification Systems. We are a leading provider of phacoemulsification systems, and have a range of systems to meet market needs. Phacoemulsification systems use disposable or reusable packs that are necessary to operate the equipment. The majority of our phacoemulsification product sales are from sales of these packs and related accessories. Sales of our phacoemulsification products represented approximately 10%, 11% and 11% of our net sales in 2004, 2003 and 2002, respectively.

 

4


Table of Contents

We currently market the following phacoemulsification systems:

 

    Sovereign – our premier phacoemulsification system is designed to reduce procedure times and provide the surgeon with increased control. The Sovereign system is available with our proprietary Occlusion Mode and WhiteStar technology, which creates less heat and turbulence in the ocular environment, giving rise to the term “cold phaco” and enabling better patient outcomes. Our WhiteStar technology also permits the system to offer bimanual, micro-incision phaco, a procedure which gives surgeons more operating flexibility over traditional techniques.

 

    Sovereign Compact -is a mid-sized phacoemulsification system designed to meet surgeons’ needs for an advanced phacoemulsification system, with the same functionality of the Sovereign system, in a smaller, more portable size. The Sovereign Compact system is also available with Occlusion Mode and WhiteStar technology.

 

    The Diplomax and Prestige – our more affordable phacoemulsification systems that are currently positioned primarily for markets outside the United States. These systems provide more basic options as compared to the Sovereign and Sovereign Compact systems while providing the necessary control during the procedure.

 

Viscoelastics. We acquired from Pfizer in June 2004 the Healon family of viscoelastics, and as a result are a leading provider of viscoelastic products. The Healon family is one of the leading brands of viscoelastics and has significantly expanded the scale of our existing viscoelastic offering, which includes our Vitrax and Vitrax II brands of viscoelastic. The different characteristics associated with each Healon product, Healon, Healon GV and Healon5, provide surgeons with a range of viscoelastic choices that combine the familiarity of the Healon line with advanced technologies to satisfy different surgical needs. Healon was the first viscoelastic introduced into the ophthalmic surgical product market and is known for its purity and ease of use. Healon GV is of a greater viscosity than the original Healon solution, which is designed for certain ophthalmic surgical procedures. Healon5 is the first and only viscoadaptive agent to exhibit properties of both cohesive and dispersive viscoelastics. Healon5 has the highest viscosity of any viscoelastic currently available and is designed to create and maintain a deep anterior chamber during surgery, which facilitates manipulation inside the eye. Our Vitrax product complements the Healon family to meet a full range of needs during surgery. Vitrax is a low molecular weight dispersive viscoelastic used during the phacoemulsification process to protect the cornea. Sales of our viscoelastic products represented approximately 10%, 3% and 2% of our net sales in 2004, 2003 and 2002, respectively.

 

Other Cataract Surgical Related Products. In addition to our IOLs, phacoemulsification equipment and viscoelastics, we also provide several ancillary products related to the cataract surgery market, including:

 

    Irrigating Solutions. We offer irrigating solutions for use in cataract surgery to help maintain space in the eye and to aid in removing residual tissue during phacoemulsification. Irrigating solutions are balanced saline solutions that are compatible with the natural fluid of the anterior segment of the eye.

 

    Custom Eye Trays. We work with partners in our local markets to offer custom eye trays to our customers. These custom eye trays typically consist of all of the ancillary items that a surgeon needs to use in a single cataract surgery, such as surgical knives, drapes, gloves and gowns. Our partners typically handle assembly, distribution and billing for the product and in most cases we receive a fee per tray from our partners.

 

    Capsular Tension Rings. In the United States, we sell the StabilEyes capsular tension ring, which is inserted into the capsular bag during cataract surgery and functions to stabilize the capsular bag during placement of an IOL. We also market and distribute the Inject-o-Ring capsular tension ring in Europe. We distribute these products under arrangements with Ophtec B.V. in the United States and Corneal in Europe, respectively.

 

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