ABBOTT INTRAOCULAR LENSES, OVDs, & ACCESSORIES

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AMOeasy, BAERVELDT, CATALYS, COMPACT INTUITIV, HEALON, HEALON GV, HEALON5, HEALON EndoCoat, HEALON Duet, One Series, OptiEdge, ProTEC, SENSAR, StabilEyes, TECNIS, TECNIS iTEC, Tri-Fix, UNFOLDER, and WHITESTAR Signature are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. © 2016 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2016CT0088 Reorder: TEC15-01 ABBOTT INTRAOCULAR LENSES, OVDs, & ACCESSORIES

Transcript of ABBOTT INTRAOCULAR LENSES, OVDs, & ACCESSORIES

AMOeasy, BAERVELDT, CATALYS, COMPACT INTUITIV, HEALON, HEALON GV, HEALON5, HEALON EndoCoat, HEALON Duet, One Series, OptiEdge, ProTEC, SENSAR, StabilEyes, TECNIS, TECNIS iTEC, Tri-Fix, UNFOLDER, and WHITESTAR Signature are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.

© 2016 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2016CT0088Reorder: TEC15-01

ABBOTT INTRAOCULAR LENSES, OVDs, & ACCESSORIES

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INDICATIONS FOR THE TECNIS® MULTIFOCAL 1-PIECE IOLs: The TECNIS® Multifocal 1-Piece Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

INDICATIONS FOR THE TECNIS® CL IOL: TECNIS® CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

INDICATIONS FOR THE TECNIS® 1-PIECE IOL: TECNIS® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

INDICATIONS FOR THE TECNIS® TORIC 1-PIECE IOL: The TECNIS® Toric 1-Piece Posterior Chamber Lenses are indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

INDICATIONS FOR THE TECNIS® FOLDABLE ACRYLIC IOLs WITH OPTIEDGE DESIGN: TECNIS® Foldable Acrylic IOLs with OptiEdge design are indicated for the visual correction of aphakia in adults in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

INDICATIONS FOR THE CATALYS® PRECISION LASER SYSTEM: The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

INDICATIONS FOR THE WHITESTAR SIGNATURE® SYSTEM: The AMO WHITESTAR Signature® Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

At Abbott, we’re focused on investing in the future of cataract surgery as well as ensuring you have the support you need to harness its full potential. With comprehensive service plans and a wide, flexible portfolio, we’re here to help you get the most out of your lens extraction investment now, and going forward.

ABBOTT TOTAL CATARACT SOLUTION

• The TECNIS® Family of IOLs continues to set the standard for proven performance and premium outcomes.

• The HEALON® Family of OVDs provides the versatility and functionality of cohesive, dispersive, and viscoadaptive viscoelastics — giving you protection, clarity, and control.

• The CATALYS® Precision Laser System allows you to take full advantage of precise incisions and outstanding fragmentation.

• The WHITESTAR Signature® System helps you optimize procedures and outcomes with switch-on-the-fly, dual-pump technology.

• The COMPACT INTUITIV System delivers outcomes-driven technologies for excellent, efficient phaco without sacrificing stability and control.

INDICATIONS FOR THE COMPACT INTUITIV SYSTEM: The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

INDICATIONS FOR HEALON5® OVD: HEALON5® OVD is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON5® OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON5® OVD can also be used to efficiently separate and control ocular tissues. The HEALON5® OVD is not designed to have any pharmacological effect.

INDICATIONS FOR HEALON® OVD: The HEALON® OVD is indicated for use as a surgical aid in cataract extraction (intra- and extracapsular), IOL implantation, corneal transplant, glaucoma filtration and retinal attachment surgery. In surgical procedures in the anterior segment of the eye, instillation of the HEALON® OVD serves to maintain a deep anterior chamber during surgery, allowing for efficient manipulation with less trauma to the corneal endothelium and other surrounding tissues. Furthermore, its viscoelasticity helps to push back the vitreous face and prevent formation of a postoperative flat chamber. In posterior segment surgery the HEALON® OVD serves as a surgical aid to gently separate, maneuver and hold tissues. The HEALON® OVD creates a clear field of vision thereby facilitating intra- and post-operative inspection of the retina and photocoagulation.

INDICATIONS FOR HEALON® GV OVD: The HEALON® GV OVD is indicated for use in anterior segment ophthalmic surgical procedures. The HEALON® GV OVD creates and maintains a deep anterior chamber, to facilitate manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON® GV OVD also can be used to efficiently maneuver, separate and control ocular tissues.

INDICATIONS FOR THE HEALON ENDOCOAT® OVD: HEALON EndoCoat® OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: Cataract surgery with an intraocular lens, Cataract surgery without an intraocular lens, Secondary intraocular lens implantation. HEALON EndoCoat® OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.

TABLE OF CONTENTS

TECNIS® Monofocal IOLs 4

TECNIS® Premium IOLs 6

Other IOLs 8

Implantation Systems 10

Ophthalmic Viscosurgical Devices 12

Accessories 14

AMOeasy 16

Cataract Returned Goods Policy 18

Important Safety Information 20

FOCUS ON EXCEPTIONAL OUTCOMES

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TECNIS® MONOFOCAL IOL

Model Optic Diameter (mm)

Optic Material and Design

Overall Length (mm) Diopter Range1 Special Features

Optical Biometry Applanation Ultrasound BiometryImplantation

SystemA-Constant SRK/T

AC Depth HofferQ

Surgeon Factor Holl.1 (mm) A-Constant2 AC Depth Surgeon

Factor (mm)3

TECNIS iTEC Preloaded Delivery System 1-Piece PCB00

6.0Hydrophobic acrylic,

biconvex, anterior aspheric surface,

U.V. blocking13.0 +5.0 to +34.0 D

ProTEC 360˚ square posterior edge, Tri-Fix offset haptics

for 3 points of fixation119.34 5.74 1.964 118.8 5.4 1.68 TECNIS iTec Preloaded

Delivery System

1-Piece ZCB00 6.0

Hydrophobic acrylic, biconvex, anterior aspheric surface,

U.V. blocking13.0 +5.0 to +34.0 D

ProTEC 360˚ square posterior edge, Tri-Fix offset haptics

for 3 points of fixation119.34 5.74 1.964 118.8 5.4 1.68 UNFOLDER®

Platinum 1 Series

3-Piece ZA9003 6.0

Hydrophobic acrylic, biconvex, anterior aspheric surface,

U.V. blocking13.0 +10.0 to +30.0 D

5˚ angulation PMMA haptics

OptiEdge ® Design119.15 5.615 1.845 119.1 5.6 1.85

UNFOLDER® Emerald T or Emerald XL

3-Piece Z9002 6.0

Silicone, biconvex, anterior aspheric

surface, U.V. blocking

13.0 +5.0 to +30.0 D10˚ angulation PMMA haptics

OptiEdge ® Design118.85 5.465 1.675 118.7 5.4 1.62 UNFOLDER®

Silver Series T

TECNIS® TORIC 1-PIECE IOL

Model Optic Diameter (mm)

Optic Material and Design

Overall Length (mm) Diopter Range1 Special Features

Optical Biometry Applanation Ultrasound BiometryImplantation

SystemA-Constant SRK/T

AC Depth HofferQ

Surgeon Factor Holl.1 (mm) A-Constant2 AC Depth Surgeon

Factor (mm)3

1-Piece ZCT150 ZCT225 ZCT300 ZCT400 ZCT450 ZCT525 ZCT600

6.0

Hydrophobic acrylic, biconvex, anterior

toric aspheric surface, U.V.

blocking

13.0 +5.0 to +34.0 DProTEC 360˚ square posterior

edge, Tri-Fix offset haptics for 3 points of fixation

119.34 5.74 1.964 118.8 5.4 1.68 UNFOLDER® Platinum 1 Series

TECNIS® MONOFOCAL IOLs

PLEASE SEE COMPLETE IMPORTANT SAFETY INFORMATION ON PAGE 20 OF THIS CATALOG.1. 0.50 diopter steps.2. A-constant theoretically derived for ultrasound biometry3. Calculated based on Holladay I formula: Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS.

A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24 and Holladay, J.T. International Intraocular Lens & Implant registry 2003. J Cataract Refract Surg 2003; 29:176-197

4. Derived from clinical evaluation results of the TECNIS® 1-Piece Platform for optical biometry5. Measurement from the ULIB website. http://www.augenklinik.uni-wuerzburg.de/ulib/c1.htm. The A-constants

listed in the ULIB table were derived from and are only valid for measurements with the Zeiss IOL Master, calculated from patient data on file (as of October 22, 2013)

6. Based on average pseudophakic human eye and “Holladay, J.T. International Intraocular Len and Implant Registry 2003. J Cataract Refract Surg 2003;29:176-197.”

7. Based on a vector sum of preoperative corneal astigmatism (preop Kcyl) and the predicted effect of surgically induced astigmatism (SIA).

Lens Model IOL Plane Corneal Plane 6 (Preop Kcyl + SIA)7

ZCT150 1.50 D 1.03 D 0.75–1.50 D ZCT225 2.25 D 1.54 D 1.50–2.00 D ZCT300 3.00 D 2.06 D 2.00–2.75 D ZCT400 4.00 D 2.74 D 2.75–3.62 D ZCT450 4.50 D 3.08 D 3.00–3.50 D ZCT525 5.25 D 3.60 D 3.50–4.00 D ZCT600 6.00 D 4.11 D 4.00–4.75 D

CORNEAL ASTIGMATISM CORRECTION RANGE

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TECNIS® MULTIFOCAL IOLs

Model Optic Diameter (mm)

Optic Material and Design

Overall Length (mm) Diopter Range1 Special Features

Optical Biometry Applanation Ultrasound BiometryImplantation

SystemA-Constant SRK/T

AC Depth HofferQ

Surgeon Factor Holl.1 (mm) A-Constant2 AC Depth Surgeon

Factor (mm)3

1-Piece ZKB00

(+2.75 D)6.0

Hydrophobic acrylic, biconvex, anterior

aspheric, multifocal optic, U.V. blocking

13.0 +5.0 to +34.0 DProTEC 360˚ square posterior

edge, Tri-Fix offset haptics for 3 points of fixation

119.34 5.74 1.964 118.8 5.4 1.68 UNFOLDER® Platinum 1 Series

1-Piece ZLB00

(+3.25 D)6.0

Hydrophobic acrylic, biconvex, anterior

aspheric, multifocal optic, U.V. blocking

13.0 +5.0 to +34.0 DProTEC 360˚ square posterior

edge, Tri-Fix offset haptics for 3 points of fixation

119.34 5.74 1.964 118.8 5.4 1.68 UNFOLDER® Platinum 1 Series

1-Piece ZMB00 (+4.0 D)

6.0Hydrophobic acrylic,

biconvex, anterior aspheric, multifocal optic, U.V. blocking

13.0 +5.0 to +34.0 DProTEC 360˚ square posterior

edge, Tri-Fix offset haptics for 3 points of fixation

119.34 5.74 1.964 118.8 5.4 1.68 UNFOLDER® Platinum 1 Series

3-Piece ZMA00 6.0

Hydrophobic acrylic, biconvex, anterior

aspheric, multifocal optic, U.V. blocking

13.0 +5.0 to +34.0 D 5˚ angulation PMMA haptics OptiEdge® Design 119.55 5.805 2.065 119.1 5.6 1.85 UNFOLDER®

Emerald Series

PLEASE SEE COMPLETE IMPORTANT SAFETY INFORMATION ON PAGE 20 OF THIS CATALOG.1. 0.50 diopter steps.2. A-constant theoretically derived for ultrasound biometry3. Calculated based on Holladay I formula: Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS.

A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24 and Holladay, J.T. International Intraocular Lens & Implant registry 2003. J Cataract Refract Surg 2003; 29:176-197

4. Derived from clinical evaluation results of the TECNIS® 1-Piece Platform for optical biometry5. Measurement from the ULIB website. http://www.augenklinik.uni-wuerzburg.de/ulib/c1.htm. The A-constants

listed in the ULIB table were derived from and are only valid for measurements with the Zeiss IOL Master, calculated from patient data on file (as of October 22, 2013)

Lens Model Add Power at Add Power at Theoretical Reading IOL Plane Spectacle Plane Distance

ZKB00 +2.75 D +2.01 D 50 cm ZLB00 +3.25 D +2.37 D 42 cm ZMB00 +4.00 D +3.00 D 33 cm

ADD POWER AT IOL AND SPECTACLE PLANE AND THEORETICAL READING DISTANCE

TECNIS® PREMIUM IOLs

pg 8 pg 9

SENSAR® IOL

Model Optic Diameter (mm)

Optic Material and Design

Overall Length (mm) Diopter Range1 Special Features

Optical Biometry Applanation Ultrasound BiometryImplantation

SystemA-Constant SRK/T

AC Depth HofferQ

Surgeon Factor Holl.1 (mm) A-Constant2 AC Depth Surgeon

Factor (mm)3

Regular Diopter AR40e

6.0Hydrophobic acrylic

biconvex, U.V. blocking

13.0 +6.0 to +30.0 D5˚ angulation

PMMA haptics OptiEdge ® Design

118.74 5.394 1.624 118.4 5.2 1.45 UNFOLDER ® Emerald XL

Low Diopter AR40E AR40M

6.0 6.0

Hydrophobic acrylic biconvex, meniscus,

U.V. blocking13.5 13.5

+2.0 to +5.5 D -10.0 to +1.5 D

5˚ angulation PMMA haptics

OptiEdge ® Design118.74 5.414 1.634 118.4 5.2 1.45 UNFOLDER ®

Emerald XL

OTHER IOLs

Not yet estimated. Please refer to Applenation Ultrasound Biometry.

INDICATIONS: SENSAR® Foldable IOLs with OptiEdge® Design are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

1. 0.50 diopter steps.2. A-constant theoretically derived for ultrasound biometry3. Calculated based on Holladay I formula: Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS.

A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24 and Holladay, J.T. International Intraocular Lens & Implant registry 2003. J Cataract Refract Surg 2003; 29:176-197

4. Measurement from the ULIB website. http://www.augenklinik.uni-wuerzburg.de/ulib/c1.htm. The A-constants listed in the ULIB table were derived from and are only valid for measurements with the Zeiss IOL Master, calculated from patient data on file (as of October 22, 2013)

FSS AND NCS CONTRACT HOLDER:FSS Contract V797P-4233B: Tecnis Lenses, Phaco equipment and consumablesNCS Contract VA797N-13-D0009: Tecnis Lenses

pg 10 pg 11

THE TECNIS iTEC PRELOADED DELIVERY SYSTEMFeatures For Implanting Cartridge Model Handpiece Model

Screw-Style Inserter TECNIS® 1-Piece Monofocal IOL only 1MTEC30 (built into system) PCB00

THE UNFOLDER® PLATINUM 1 SERIES IMPLANTATION SYSTEMFeatures For Implanting Cartridge Model Handpiece Model

Screw-Style Inserter

TECNIS ® 1-Piece Monofocal IOL,

TECNIS ® Toric 1-Piece IOL, and

TECNIS ® Multifocal 1-Piece IOLs

1MTEC30 DK7796

THE ONE SERIES ULTRA IMPLANTATION SYSTEMFeatures For Implanting Cartridge Model Handpiece Model

Implantation Forceps

TECNIS ® 1-Piece Monofocal IOL,

TECNIS ® Toric 1-Piece IOL, and

TECNIS ® Multifocal 1-Piece IOLs

DK7726

THE UNFOLDER® EMERALD XL SERIES IMPLANTATION SYSTEMFeatures For Implanting Cartridge Model Handpiece Model

Screw-Style Inserter

TECNIS ® 3-Piece Acrylic IOL

Sensar ® IOL

TECNIS ® Multifocal 3-Piece IOL

EMERALDC30 EMERALDXL

THE UNFOLDER® SILVER T SERIES IMPLANTATION SYSTEMFeatures For Implanting Cartridge Model Handpiece Model

Screw-Style Inserter TECNIS ® 3-Piece Silicone IOL PSCST30 SILVERT

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR ABBOTT IMPLANTATION SYSTEMS:Rx Only

ATTENTIONReference the labeling for a complete listing of Indications and Important Safety Information.

INDICATIONS FOR THE UNFOLDER® PLATINUM IMPLANTATION SYSTEM: The Model DK7796 Handpiece is used in combination with the Model 1MTEC30 cartridge to fold and assist in inserting AMO® Acrylic 1-Piece Intraocular Lenses, ONLY into the capsular bag.

INDICATIONS FOR THE SILVER SERIES IMPLANTATION SYSTEM: The UNFOLDER® Silver Series Implantation System is used to fold and assist in inserting CLARIFLEX, PHACOFLEX II, CeeOn, TECNIS Silicone, and ARRAY Silicone ≤ 24.0 D IOLs only, into the eye.

INDICATIONS FOR THE UNFOLDER® EMERALD SERIES IMPLANTATION SYSTEM: The UNFOLDER® Emerald Series Implantation System is used to fold and assist in inserting AMO acrylic intraocular lenses, ONLY into the capsular bag.

WARNINGS: AMO® single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user.

IMPLANTATION SYSTEMS

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HEALON® OVD (1.0% SODIUM HYALURONATE) Model No. Sizes Classification Molecular Weight Production

10290757 10295210 10290953

0.40 mL0.55 mL0.85 mL

Cohesive 4,000,000 daltons

- Terminal sterilization - Aseptically packaged - Not made with natural rubber latex

- Storage at 2 to 8º C (36 to 46º F)- Cannula size: 27 gauge

HEALON GV® OVD (1.4% SODIUM HYALURONATE) Model No. Sizes Classification Molecular Weight Production

10294701 10294801

0.55 mL0.85 mL Cohesive 5,000,000

daltons

- Terminal sterilization - Aseptically packaged - Not made with natural rubber latex

- Storage at 2 to 8º C (36 to 46º F)- Cannula size: 27 gauge

HEALON5® OVD (2.3% SODIUM HYALURONATE) Model No. Sizes Classification Molecular Weight Production

10290051 0.60 mL Viscoadaptive 4,000,000 daltons

- Terminal sterilization - Aseptically packaged - Not made with natural rubber latex

- Storage at 2 to 8º C (36 to 46º F)- Cannula size: 25 gauge

HEALON ENDOCOAT® OVD (3% SODIUM HYALURONATE) Model No. Sizes Classification Molecular Weight Production

VT585U 0.85 mL Dispersive 800,000 daltons- Terminal sterilization - Aseptically packaged- Not made with natural rubber latex

- Refrigeration not required (2 to 25º C / 36 to 77º F)

- Cannula size: 25 gauge

HEALON DUET® DUAL PACK Model No. Sizes Classification Molecular Weight Production

10290080HEALON® OVD 0.55 mL/ HEALON EndoCoat® OVD

0.85 mLDual Pack

4,000,000 daltons

800,000 daltons

- Terminal sterilization - Aseptically packaged- Not made with natural rubber latex- Comes in 2 blister packages

- HEALON® OVD storage at 2 to 8º C (36 to 46º F)- HEALON EndoCoat® OVD storage at 2-8º C (36 to 77º F)- HEALON® OVD cannula size: 27 gauge- HEALON EndoCoat® OVD cannula size: 25 gauge

HEALON® & HEALON5® ULTIMATE DUAL PACK Model No. Sizes Classification Molecular Weight Production

10290060 HEALON® OVD 0.55 mL/ HEALON5® OVD 0.60 mL Dual Pack 4,000,000

daltons- Terminal sterilization - Aseptically packaged - Not made with natural rubber latex

- Storage at 2 to 8º C (36 to 46º F)- HEALON® OVD cannula size: 27 gauge- HEALON5® OVD cannula size: 25 gauge

PLEASE SEE COMPLETE IMPORTANT SAFETY INFORMATION ON PAGE 20 OF THIS CATALOG.

OPHTHALMIC VISCOSURGICAL DEVICES

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BAERVELDT® GLAUCOMA IMPLANT Product Number Model Description Special Features

23030817 BG101-350 Surface area: 350 mm2

– Large surface area – Low implant profile – Patented fenestrations

23030818 BG102-350 Surface area: 350 mm2 pars plana model

23030819 BG103-250 Surface area: 250 mm2

STABILEYES® CAPSULAR TENSION RING Product Number Type

STBL12US 12/10 mm ring

STBL13US 13/11 mm ring

BALANCED SALT SOLUTION Product Number Description Quantity

BSS500 Balanced salt solution 500 mL glass bottle 12 bottles per case

INDICATIONS FOR THE BAERVELDT® GLAUCOMA IMPLANT: For use in patients (with prior vitrectomy for Pars Plana) with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma, aphakic/pseudophakic glaucomas, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc.

ACCESSORIES

AMOeasy.com inventory management and ordering system.

The AMOeasy system provides quick, accurate online ordering and tracking of all your AMO implant and cataract products. With the AMOeasy system, you can manage your implant inventory, view real-time reports, place orders, and track your existing orders 24 hours a day, 7 days a week. In addition, AMOeasy simplifies your ordering process by allowing you to create automated lists for frequently ordered products.

Saving your most precious resource:

[ time. ]

Sign up today by visiting [ www.AMOeasy.com ]

pg 18 pg 19

At Abbott, we value our customers and take pride in the quality of all products we manufacture and distribute. As such, effective April 4, 2014, we will only accept for credit or exchange for products that meet the criteria outlined below in the Returned Goods Policy.

RETURNS GOODS AUTHORIZATION (RGA) Should you find it necessary to return merchandise, please call one of the Abbott Customer Support toll-free numbers listed below, and your Customer Support Representative will help you arrange your product return. An RGA number must accompany all products returned to ensure acceptance at our warehouse locations.

IOLs/SURGICAL SUPPORT PRODUCTS: Abbott Customer Service: 877-AMO-4-LIFE (266-4543)

Phaco Equipment: Abbott Equipment Sales: 949-440-4700 #6The RGA number you obtain must be clearly marked on the outer package and on all paperwork accompanying your return. This number should be referenced when following up on your return transaction. The customer is responsible for ensuring that the product is packaged appropriately to guard against damage while in transit. Return transportation charges will be paid by the customer, unless otherwise authorized by Customer Support. All products are eligible for credit up to 90 days of purchase with the exception of the following:

CATARACT RETURNED GOODS POLICY

AMOeasy, BAERVELDT, CATALYS, COMPACT INTUITIV, HEALON, HEALON GV, HEALON5, HEALON EndoCoat, HEALON Duet, One Series, OptiEdge, ProTEC, SENSAR, StabilEyes, TECNIS, TECNIS iTEC, Tri-Fix, UNFOLDER, and WHITESTAR Signature are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.

© 2016 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2016CT0088Reorder: TEC15-01

RETURN POLICY CONDITIONS • Credit for returned goods will be issued at the original purchase price if returned within 90

days of date of purchase and Abbott is able to resell the product. Credit will not be issued for product that has been opened or the packaging has been compromised. Credit will not be issued if returned product is not accompanied with a returned goods authorization number issued by Abbott.

• Returns are subject to final count upon receipt in the Abbott warehouse.

• Abbott reserves the right to accept or reject the merchandise returned for either credit or exchange.

• Abbott reserves the right to promptly destroy all merchandise returned that is not eligible for credit or exchange.

CATARACT RETURNED GOODS WAREHOUSE LOCATIONSUnopened Product AMO ReturnsC/O OHLRGA#1101 Whitaker RoadPlainfield, IN 46168

Product Complaints or Opened Product Abbott Attn: Helen Garcia RGA# 1700 E. St. Andrew Place Santa Ana, CA 92705

Phaco Equipment/Handpieces Abbott Attn: Phaco Depot Repair RGA# 510 Cottonwood Milpitas, CA 95035

NONRETURNABLE PRODUCTS • Expired and/or opened, direct purchase product

• Product deteriorated or damaged due to conditions beyond the control of the manufacturer, such as improper storage, heat, cold, water, smoke, and customer applied markings, such as labels, pen markings, etc

• Any product that Abbott is unable to resell, opened cartons (broken safety seals), etc.

• OVD products

PRODUCTS ELIGIBLE FOR EXCHANGE ONLY • IOLs/CTRs purchased on a “Bulk Purchase” or “Starter Stock” agreement can only be

exchanged for the same IOL/CTR model

• All opened IOLs, CTRs, and shunts can be exchanged for the same model

• Defective OVD products

PHACO EQUIPMENT AND HANDPIECES • Product that is returned within 45 days of the purchase date as shown on the corresponding

invoice, in its original, undamaged condition is eligible for credit or exchange less a restocking fee

• If phaco equipment is returned within 45 days of purchase, a restocking fee of 30% of equipment invoice price is assessed.

• Should phaco equipment be returned damaged, reconditioning charges may be assessed.

• No phaco equipment returns are accepted for credit after 45 days following installation.

• Should any phaco equipment be received damaged from Abbott, please contact Abbott Equipment Sales at 949-440-4700 #6 if you are refusing delivery due to “apparent damage.” Apparent damage is defined as merchandise that arrives to you in a damaged condition. The delivery carrier driver should complete an inspection report.

pg 20 pg 21

IMPORTANT SAFETY INFORMATION FOR ABBOTT PRODUCTS:Rx OnlyATTENTION: Reference the labeling for a complete listing of Indications and Important Safety Information.

IMPORTANT SAFETY INFORMATION FOR TECNIS® 1-PIECE IOLWARINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the TECNIS® 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The TECNIS® 1-Piece IOL should not be placed in the ciliary sulcus. Precautions: Do not reuse, resterilize, or autoclave. ADVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece IOL was macular edema, which occurred at a rate of 3.3%. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).

IMPORTANT SAFETY INFORMATION FOR TECNIS® TORIC 1-PIECE IOLWARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The clinical study did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. The TECNIS® Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS® Toric 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder.PRECAUTIONS: Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator (www.TECNISToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. Refer to the TECNIS® Toric 1-Piece IOL Directions for Use for a complete description of the preexisting conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the clinical study. Do not reuse, resterilize, or autoclave. ADVERSE EVENTS: The most frequently reported adverse event that occurred with the TECNIS® Toric 1-Piece IOL was surgical reintervention, which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included macular edema, which occurred at a rate of 2.9% and retinal detachment which, occurred at a rate of 0.6%.

IMPORTANT SAFETY INFORMATION FOR THE TECNIS® CL IOLWARNINGS: Physicians considering lens implantation under any of the conditions described in the TECNIS® CL IOL Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Do not place in the ciliary sulcus.PRECAUTIONS: Do not resterilize or autoclave. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or over 45°C. Avoid exposure to volatile chemicals.ADVERSE EVENTS: Significant reported adverse event that occurred at a rate greater than 1% during the clinical trials of the parent lens models for the TECNIS® CL intraocular lens macular edema, hyphema, and secondary glaucoma.

IMPORTANT SAFETY INFORMATION FOR HEALON® FAMILY OF PRODUCTS CONTRAINDICATIONS: There are no known contraindications to the use of the HEALON OVDs when used as recommended.PRECAUTIONS: Remove carefully and completely from the eye by irrigating or aspirating to reduce the risk of early postoperative intraocular pressure (IOP) spikes. Patients with preexisting glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and surgical complications are more susceptible to postoperative IOP and should be treated with additional care. Carefully monitor intraocular pressure and treat with pressure lowering therapy if required. In posterior segment procedures with HEALON® OVD in aphakic diabetic patients,

special care should be exercised to avoid using large amounts of the product. Express a small amount of product prior to use and carefully examine the remainder as it is injected into the eye. Because HEALON® OVDs contain trace amounts of protein from avian tissues, physicians should be aware of potential allergic risks, such as postoperative inflammation, that may occur with the injection of biological materials. WARNINGS: The HEALON EndoCoat® OVD delivery system is not designed or intended to be attached to instruments other than the one provided with the product, as it may cause cannula detachment. When using HEALON EndoCoat® OVD for surgery, the eye should not be irrigated with any solution containing benzalkonium chloride, because the mixing of quanternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate results in the formation of a precipitate. ADVERSE EVENTS: Increased intraocular pressure has been reported after use of HEALON® OVDs. In rare instances, postoperative inflammatory reactions as well as corneal edema and corneal decompensation have been reported. Conjunctival hemorrhage has been reported for HEALON5® OVD.

IMPORTANT SAFETY INFORMATION FOR THE CATALYS® PRECISION LASER SYSTEMIMPORTANT SAFETY INFORMATION: Mild Petechiae and subconjunctival hemorrhage can occur due to vacuum pressure of the suction ring. Potential complications and adverse events include any of those generally associated with cataract surgery.

IMPORTANT SAFETY INFORMATION FOR WHITESTAR SIGNATURE®

WARNINGS: Risks and complications of cataract surgery may include broken ocular capsule or corneal burn. This device is only to be used by a trained licensed physician.

IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV SYSTEMIMPORTANT SAFETY INFORMATION: Do not activate the Phaco and Vitrectomy handpieces with the tips in air as this reduces the useful life of the handpiece and the cutter. Do not attempt to use the system if it fails to perform properly and do not use near flammable objects, anesthetics, gases, fluids, and oxidizing agents. Obtain qualified advice prior to the use of the COMPACT INTUITIV System on patients with a cardiac pacemaker, as the system might interfere with this device. Ensure that the irrigation solution bottle height and fluid level are monitored at all times as a low bottle or empty bottle will affect intraocular pressure during aspiration and may lead to inadvertent chamber shallowing or collapse, aspiration or abrasion of the iris or other eye tissue, and ultrasonic wound burn. Do not come into contact with grounded metal parts or parts that have appreciable capacitance to ground. The use of an antistatic mat is recommended. Use proper handling and disposing methods for biohazards when disposing single-use components. Follow good operating room procedures to prevent injury or contamination. Place all monitoring electrodes or other types of equipment as far from the COMPACT INTUITIV System as possible. A high current limiting device is recommended for the protection of such systems. Do not use needle monitoring electrodes. Keep the diathermy cord, handpieces, leads and active electrodes away from the patient. Do not allow skin to skin contact of the patient, for example, between the arms and torso and insert dry gauze to avoid contact, as appropriate. Do not use near conductive materials, and renew electrode cables upon evidence of deterioration. All non-sterile accessories must be sterilized prior to use. Examine all handpieces closely prior to use, as contaminated or damaged system accessories can cause patient injury. Do not use non-AMO approved products with the COMPACT INTUITIV System.

IMPORTANT SAFETY INFORMATION FOR BAERVELDT ® GLAUCOMA IMPLANT: WARNINGS: Do not use the device if sterile package integrity has been compromised. Do not resterilize the implant by any method. Do not reuse the implant. Do not store at temperatures above 45°C (113°F). CONTRAINDICATIONS: Bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulites, bacteremia or septicemia, active scleritis and/or no light perception.ADVERSE EVENTS: The complications during and after surgery include, but are not limited to: chorodial hemorrhage, hyphema, serous choroidal effusion, hypotony, flat anterior chamber, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis and diplopia.

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IMPORTANT SAFETY INFORMATION FOR THE TECNIS® MULTIFOCAL FAMILYOF 1- PIECE IOLsWARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions. PRECAUTIONS: Prior to surgery, inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. The long term effects of intraocular lens implantation have not been determined. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. Do not reuse, resterilize or autoclave.ADVERSE EVENTS: The rates of surgical re-interventions, most of which were non-lens related, were statistically higher than the FDA grid rate for both the ZMB00 (+4.00 D) and ZLB00 (+3.25 D) lens models. For the ZMB00, the surgical re-intervention rates were 3.2% for first eyes and 3.3% for second eyes. The re-intervention rate was 3.3% for both the first and second eyes in the ZLB00 group.

IMPORTANT SAFETY INFORMATION FOR THE SENSAR® FOLDABLE IOLs WITHOPTIEDGE DESIGNPRECAUTIONS: Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not reuse lens. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with The UNFOLDER® Implantation System for the amount of time the IOL can remain in the cartridge before the IOL must be discarded. When the UNFOLDER® Emerald Series Implantation System is used improperly, the haptics of the SENSAR lens may become crimped or broken. Please refer to the specific instructions for use provided with the UNFOLDER® Emerald Series Implantation System. WARNINGS: Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: 1. Recurrent severe anterior or posterior segment inflammation or uveitis. 2. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases. 3. Surgical difficulties at the time of cataract extraction that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss). 4. A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible. 5. Circumstances that would result in damage to the endothelium during implantation. 6. Suspected microbial infection. 7. Children under the age of 2 years are not suitable candidates for intraocular lenses. 8. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support. 9. Lenses <4.0D are not intended, nor should they be used, for a clear lens exchange. 10. Special consideration should be given to the dimensions of lenses at the extreme end of the power range (<4.0D) in relation to the anatomical clearances in the patient’s eye. The potential impact of factors such as optic central thickness, optic edge thickness, and overall lens size on the patient’s long-term clinical outcome should be carefully weighed against the potential benefit associated with the implantation of an intraocular lens. The patient’s clinical progress should be carefully monitored. 11. AMO IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of AMO single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. Since the clinical study of the Model AR40 was conducted with the lens being primarily implanted in the

capsular bag only, there are insufficient clinical data to demonstrate its safety and efficacy for placement in the ciliary sulcus. ADVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trials of the lens was anterior lens tissue ongrowth, which occurred at a rate of 11.3%. Other reported adverse events include macular edema at 0.8%, and endophthalmitis, lens dislocation, hypopyon, and secondary surgical intervention at 0.3%.

IMPORTANT SAFETY INFORMATION FOR THE TECNIS® FOLDABLE ACRYLIC IOLsWITH OPTIEDGE DESIGNWARNINGS: Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: recurrent severe anterior or posterior segment inflammation or uveitis, patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases, surgical difficulties at the time of cataract extraction that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss), a distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, circumstances that would result in damage to the endothelium during implantation, suspected microbial infection, children under the age of 2 years are not suitable candidates for intraocular lenses, and patients in whom neither the posterior capsule nor zonules are intact enough to provide support. Since the clinical studies of lens models AR40 and 911A were conducted with the lens being primarily implanted in the capsular bag only, there are insufficient clinical data to demonstrate its safety and efficacy for placement in the ciliary sulcus. PRECAUTIONS: Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the UNFOLDER® EmeraldT or EmeraldXL Implantation Systems for the amount of time the IOL can remain in the cartridge before the IOL must be discarded. When The UNFOLDER® Emerald T or Emerald XL Implantation Systems are used improperly, the haptics of the TECNIS® Foldable Acrylic lens may become crimped or broken. Please refer to the specific instructions for use provided with the UNFOLDER® Emerald T or Emerald XL Series Implantation Systems. ADVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trials of the parent lens models for the TECNIS® foldable acrylic intraocular lens was anterior lens tissue ongrowth, which occurred at a rate of 11.3%. Other reported adverse events include macular edema at 0.8%, and endophthalmitis, lens dislocation, hypopyon, and secondary surgical intervention at 0.3%. Reported adverse events during another clinical trial of the parent lens models for the TECNIS® foldable acrylic intraocular lens was surgical intervention (0.9%), corneal decompensation (0.2%), and macular edema at 3.8%.

IMPORTANT SAFETY INFORMATION FOR TECNIS iTEC PRELOADEDDELIVERY SYSTEMWARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. Do not attempt to disassemble, modify or alter the device or any of its components. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the cartridge. Do not push the plunger forward to fully advance the lens until ready for lens implantation. Discard if the lens has been fully advanced for more than 1 minute.PRECAUTIONS: Do not reuse, resterilize, reprocess, or autoclave the device. Do not use if the device has been dropped or if any part was inadvertently struck while outside the shipping case. The lens should not be placed in the ciliary sulcus. ADVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%. Other reported events occurring in less than 1% of patients were secondary surgical intervention (0.8%, vitrectomy) and lens exchange (0.8%, due to torn lens haptic).

The legacy you leave is the life I live. My vision is everything to me, and even the best surgical technique can’t compensate for an inferior IOL. Don’t trust my vision to anything less than the very best in optics. Give me the sharpest vision I deserve. Give me TECNIS® IOLs.

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