Intraocular Lenses

Leading The Way

in Precision

www.lenstec.com

Lenstec products are designed in Florida and manufactured

in Barbados, in a facility that has British Standards

Institution and US Food & Drug Administration approval.

In late 2009, Lenstec completed a full FDA manufacturing

inspection for both our fi rst two IOLs (The Tetrafl ex Active

Lifestyle™ IOL & the Softec HD™ Bi-Aspheric Quarter

Diopter IOL). Following completion of the manufacturing

inspection, we achieved our fi rst FDA Approval for the

Softec HD lens in April of 2010. We then submitted for,

and achieved, our 2nd FDA PMA Approval for the Softec 1

in June of 2010 we now hold FDA approvals for Softec 1,

Softec HD, Softec HDO and Softec HD PLI. Lenstec is one of

only 8 companies in the world to be awarded FDA Approval

to sell IOLs within the USA. The company also holds

approvals for products in Europe, Japan, Canada, Australia

and China.

Lenstec IOLs represent the pinnacle of medical device

design, with optimized optic and haptic designs. The

fl agship Lenstec HD optic design is used across the range

of cataract and refractive lenses. Haptic confi gurations are

tapered, modifi ed C loops for Softec range and patented

four-point fi xation for refractive SBL-3 and Tetrafl ex models.

Lenstec lenses are manufactured by lathe-cutting from

premium hydrophilic acrylic materials. Micro-lathe and

milling technology provides extreme accuracy in lens

characteristics, including Dioptric Power, 360-degree

square edge and surface quality. Lenstec lenses therefore

excel in design and clinical performance.

» Softec 1 foldable acrylic lenses for high volume, low

cost cataract surgery

» Premium cataract lenses Softec HD, Softec HDY

(yellow) with zero aberration aspheric optics,

which are the most accurate lenses available. The Softec

HD is available in a pre-loaded injector

» For refractive surgery, we off er the SBL-3 (segmented

bi-focal) and Tetrafl ex HD (accomodative lens)

» For cases where the surgeon wants to minimize the

possibility of negative dysphotospia, our aspheric

Softec HDO.

» Specialty 3-Piece Acrylic Foldable lenses for sulcus

placement.

» Accessories - Injectors (single use or reusable), Cartridges,

Viscoelestics, Tension rings.

» Hydrophilic IOLs have been reported to have lower

infl ammatory response making them ideal for diabetic,

uveitis, and glaucoma patients 3,4

» Lenstec Lathe cut lenses provide superior optic and

high resolution effi ciency 11

» Lenstec has No reported incidence of glistening or

vacuoles in more than 5 million implants over 5 years 11

» Lenstec Hydrophilic material has few dysphotopsias due to

lower refractive index which minimizes problems with glare

and halos, compared to high index hydrophobic lenses 5,6

Lenstec Premium Intraocular Lenses Lenstec - Certifi ed Manufacturing Quality

Lens Design and Lens Properties

IOL Range

Advantages of Hydrophilic Acrylic (26% water content)

360-Degree Square Edge Technology

3. Schaureberger J, Kruge A, Mullner – Eldenbock A, Petternel V, Suolba G, Amon M. Course of postop infl ammation after implantation of 4 types of foldable IOL’s. J Cataract Refract Surg. 1999 Aug (8) 1116 – 1120

4. Abelo – Formonek C, Amon M, Schauerberger J, Kruger A, Nepp J. Schild G. Results of hydrophilic, hydrophobic and silicone IOL’s in uveitic eyes with cataract: comparision to control. J Cataract Refract Surg 2002 July 28 (7) 1141 - 1152

5. Davidson A. J Positive and negative dysphotopsia in patients with acrylic intraocular lenses, J Cataract Refract Surg. 2000 Sep;26(9):1346-55.

6. Olson R. Demystifying Dysphotopsia. Review of Ophthalmology Vol No 12:01 issue 1/15/2005

11. Data on fi le at Lenstec

1 2 32

13

» Neutral aspheric aberration surface and 100% optic size in

Softec HD, HDO, HDY, Tetrafl ex HD, SBL-3.

» Lens Stability - we won’t compromise edge thickness and

sacrifi ce one of the most stable designs on the market.

» Quarter diopter steps in the range from +15D to +25D.

» Tighter manufacturing tolerance in the range from +15D to

+25D is +/- 0.11D – the best in the industry (ISO standard is

0.4D).

Softec HD, HDY and HDO ‘’Zero’’ Aberration

» Equal Bi-Aspheric

» Less sensitive to decentration or tilt 12,13

» Ideal for all corneal profi les 12

» Enhanced depth of vision 7

Softec HD addresses the issue of spherical aberration inherent

in conventional monofocal spherical IOLs by adjusting the

optic with a patented design on both the anterior and

posterior surfaces. Softec HD performs exceptionally over

a wider range of corneal shapes and alignment errors than

Negative Aspheric IOLs. 12,14,15,16

Natural “Decentration” is inherent in all eyes and may

contribute to poor vision with Negative aspheric IOLs. Angle

Kappa, a misalignment of the visual axis and pupillary axis,

may contribute to alignment errors. Based on bell curve

distribution approximately 8 – 10% of patients have severe

anatomical “decentration”.

» Many surgeons do not know that a great degree of error

potentially exists within the labeling of every “standard”

IOL manufactured

» For any given patient, the labeling of standard IOLs

introduces a potentially signifi cant discrepancy between

the targeted and the labeled IOL power.

New Gold Standard: More Options, No OverlapDiopter Size Does Matter - 0.25 D vs. 0.50 D…that‘s only Half The Story

Bi-Aspheric Equal Conic Zero Aberration IOL

± 0,11 D Softec IOL ToleranceNon-Overlapping, Quarter Diopter Increment

± 0,4 D ISO Standard IOL ToleranceOverlapping, Half Diopter Increment

Old Standard

19,5 D 19,75 D 20,0 D 20,25 D 20,5 D

19,39 to 19,61 D 19,64 to 19,86 D 19,89 to 20,11 D 20,14 to 20,36 D 20,39 to 20,61 D

The Clinical Evidence

Data across multiple facilities indicates that the prediction

error distribution is enhanced to a clinically meaningful

level with the Softec HD/HDY. Tighter tolerances & smaller

lens diopter increments provide more accurate results. More

accurate results provide improved postoperative visual

acuity.

Standard (success %) Gold Standard (success %)

± 0,25 D = 40% ± 0,25 D = 55%

± 0,50 D = 70% ± 0,50 D = 90%

± 1,00 D = 90% ± 1,00 D = 100%

19,5 D 20,0 D 20,5 D

19,1 to 19,9 D 20,1 to 20,9 D19,6 to 20,4 D

Key Benefi ts of Lenstec Lenses and Unsurpassed Optic Quality in the HD Series

2. Thilos L, Hong X, Bradley A, Chang X. Statistical variation of aberration structure and image quality in a normal population of healthy eyes. J. Opt. Soc. Am A, Vol 19. No 21/Dec 2002 » 7. Craig J, Shah S, Wolff sohn J. Clinical evaluation of the Softec HD

aberration-free aspheric intraocular lens. Submitted for publication. » 12. Sarver E. Theoretical optical performance of an equal conic intraocular lens and comparison to spheri cal and aspheric IOLs. AAO Presentation 2005 » 13. Johansson B, Sundelin S,

Wikberg-Matsson A, Unsbo P, Behndig A. Visual and optical performance of the Akreos Adapt Advanced Optics and Tecnis Z9000 intraocular lenses: Swedish multicenter study. J Cataract Refract Surg 2007;33:1565-72 » 14. Denoyer A, Denoyer L, Halfon J,

Majzoub S, et al. Comparative study of aspheric intraocular lenses with negative aberration or no aberration. J Cataract Refract Surg. 2009: 35 496 – 503 » 15. Ferrer-Blasco T. Eff ect of partial and full correction of corneal spherical aberration on visual acuity

and contrast sensitivity. J Cataract Refract Surg. 2009: 35: 949 – 951 » 16. Werner J. Elliott SL, Choi SS, Doble N, Spherical aberration yielding optimum visual performance: Evaluation of intraocular lenses using adaptive optics simulation. J Cataract Refract Surg.

2009: 35: 1229 – 1233 » 17. Nanavaty M, et al. Wavefront aberrations, depth of focus, and contrast sensitivity with aspheric and spherical intraocular lenses: fellow eye study. J Cataract Refract Surg. 2009; 35: 663 - 671

Studies have shown that

Aspheric IOLs provide patients

with signifi cant optical benefi ts

over traditional spherical surface

IOLs. 2,12,17

Clinical Success

SBL 3 Tetrafl ex HD Softec HD Softec HDY

Optic Size 5.75 mm 5.75 mm 5.75 mm 5.75 mm

Optic Type Bi-aspheric Bi-aspheric Bi-aspheric Bi-aspheric

Length 11.00 mm 11.50 mm /10.75 mm 12.00 mm 12.00 mm

Haptic Style Closed Loops Closed Loops Modifi ed C Modifi ed C

Angulation 0 Degrees 5 Degrees 0 Degrees 0 Degrees

Positioning Holes 1 0 0 0

Construction 1 Piece 1 Piece 1 Piece 1 Piece

Optic Material Acrylic

(26% Water Content)

Acrylic

(26% Water Content)

Acrylic

(26% Water Content)

Acrylic

(26% Water Content)

A/C Depth 5.10 mm 5.10 mm 5.10 mm 5.10 mm

A Constant (Contact Biometry) 118.0 118.0 118.0 118.0

A Constant Optimized (Non-Contact Biometry)

Haigis a0 = 1.02 a1 = 0.40 a2 = 0.10 a0 = 0.92 a1 = 0.40 a2 = 0.10 a0 = 0.92 a1 = 0.40 a2 = 0.10

SRT/T A=118.43 A=118.57 A=118.43 A=118.43

Holladay-1 sf=1.47 sf=1.54 sf=1.47 sf=1.47

Hoff er Q pACD=5.22 pACD=5.32 pACD=5.22 pACD=5.22

Diopter Steps Whole +10.00 to +36.00 +5.00 to +36.00 +5.00 to +36.00 +5.00 to +36.00

Half +10.50 to +35.50 +5.50 to +29.50 +10.50 to +29.50 +10.50 to +29.50

Quarter +15.00 to +25.00 +15.00 to +25.00 +15.00 to +25.00 +15.00 to +25.00

Technical Specifi cations

A Constant and A/C Depth fi gures shown are strictly guidelines for the calculation of implant power. Lenstec recommends that

surgeons develop their own values based on technique, measuring equipment, and desired postoperative results. For Haigis see:

http://www.augenklinik.uni-wuerzburg.de/ulib/c2.htm.

www.lenstec.com

Softec 1 Softec HDO Softec III LH-3000

Optic Size 5.75 mm 5.75 x 6.50 mm 6.00 mm 6.00 mm

Optic Type Bi-convex Bi-aspheric Bi-convex Bi-convex

Length 12.00 mm 12.50 mm 12.75 mm 13.00 mm

Haptic Style Modifi ed C Modifi ed C Modifi ed C Modifi ed C

Angulation 0 Degrees 0 Degrees 0 Degrees 0 Degrees

Positioning Holes 0 0 0 0

Construction 1 Piece 1 Piece 3 Piece 3 Piece

Optic Material Acrylic

(26% Water Content)

Acrylic

(26% Water Content)

Acrylic

(26% Water Content)

Acrylic

(26% Water Content)

A/C Depth 5.10 mm 5.10 mm 4.97 mm 4.97 mm

A Constant (Contact Biometry) 118.0 118.0 118.0 118.0

A Constant Optimized (Non-Contact Biometry) Haptic material Haptic material

Haigis a0 = 0.92 a1 = 0.40 a2 = 0.10 Polyimide Polyimide

SRT/T A=118.43 A=118.43

Holladay-1 sf=1.47 sf=1.48

Hoff er Q pACD=5.22 pACD=5.22

Diopter StepsWhole -5.00 to +36.00 +5.00 to +36.00 -5.00 to +36.00 -5.00 to +36.00

Half +10.50 to +29.50 +10.50 to +29.50 +10.50 to +29.50 +10.50 to +29.50

Quarter +15.00 to +25.00

3-piece Acrylic Foldable IOLS

Softec1 Softec III LH-3000

Lenstec is an ISO 13485 Registered company manufacturing

CE Marked products.

Lenstec off ers Capsular Tension Rings in both clear and blue

PMMA, providing high fl exibility, high memory control and are

easy to insert manually or with any available injector.

Both designs are applicable when the zonules are missing or

damaged, in cases of lens luxation during Phaco complications,

zonular breakage during sudden unfolding of a foldable lens,

for repositioning of a lens or if decentration of same. Other uses

for myopia, pseudoexfoliation, eyes undergoing vitrectomy,

trauma and multifocal implant.

Implantation off ers various advantages including: force

distribution acting circumferentially on the capsule; less risk

of capsular shrinking; less risk of capsular fi brosis; and more

reliable IOL centration.

In a Convenient 10-Pack

Dispenser for single use injectors. A safe, convenient and cost-

eff ective solution to micro-incision simplicity. Increases safety,

reduces preparation time for maximum control.

Manufactured to high medical standards, LensVisc solutions are

packaged in convenient, sterile, single-use syringes. LensVisc

solutions are biocompatible and completely transparent with

no air bubbles, and off er ideal viscosity for ophthalmic surgery,

protecting the capsular bag structural integrity during surgery

as well as reducing eye dehydration and infl ammation.

Surgical Support ProductsCapsular Tension Rings

Disposable Injectors

LensVisc Viscoelastic

Size LR-1300 LR-1400 LR-1300B LR-1400B

Open 12.30 14.30 12.30 14.30

Compressed 10.00 12.00 10.00 12.00

Colour Clear Clear Blue Blue

LC1620I LC16I LC16SI LC1645S Cartridge

Info Single use

Micro-incision injector

with LC1620 cartridge

Single use

Micro-incision injector

with LC16 cartridge

Single use

Micro-incision injector

with LC16S cartridge

External diameter 1.6 mm

Internal diameter 1.4 mm

Bevel 20 degree

Box 10-Pack 10-Pack 10-Pack

LensVisc MC Viscoelastic Solution LensVisc HA Viscoelastic Solution

Package 1.5 ml of MC (Hydroxypropyl Methylcellulose 2%) 1.0 ml of HA (Hyaluronic Acid 1.4% or 2%)

Cannula 23 gauge cannula 27 gauge cannula

LensVisc HA is a totally synthetic material and

contains no animal by-products

0.15 mm0.15 mm

Lenstec... for True Innovation

Lenstec, Inc. is a medical device corporation serving the global

ophthalmic surgical market. Lenstec manufactures a range of

premium intraocular lenses and associated devices for cataract

and refractive surgery. Founded in 1993 as a technology

transfer company, Lenstec built 8 IOL laboratories around the

world. Currently more IOLs are made with Lenstec technology

worldwide than with any other system, and the company

has an established reputation for rapid prototype design and

development, and high quality manufacturing.

Lenstec started manufacturing in Barbados in 1995 and we

have supplied more than 7,000,000 lenses worldwide.

At Lenstec we continuously strive to improve vision

possibilities through research, testing and partnerships with

the world’s leading ophthalmologists. We welcome your

interest in the company and any questions you may have

about our products and services or opportunities to partner

with us.

R&D to Manufacturing from Lenstec

World Headquarters

Lenstec, Inc.

1765 Commerce Ave. N.

St. Petersburg, FL 33716

USA

Tel: 727-571-2272

Fax: 727-571-1792

Email: lenstec@lenstec.com

PKB 40 Rev1

Lenstec UK

Lenstec (Barbados) Inc. Lenstec House

Unit 8, Mariner Court Calder Park

Wakefi eld WF4 3FL

UK

Tel: +44 (0)1924 382 678

Fax:+44 (0)1924 850 454

Email: lenstecuk@lenstec.com

Lenstec Barbados

Lenstec (Barbados) Inc.

Airport Commercial Centre

Pilgrim Road, Christ Church BB17092

Barbados

Tel: 246-420-6795

Fax: 246-420-6797

Email: lenstecbarbados@lenstec.com

Lenstec Regional Offi ce

Trenčianska 47821 09 BratislavaSlovak Republiccell: +421 905 798 760e-mail: jkriska@lenstec.com

www.lenstec.com