Surgical Guide

ExcEptional Visual pErformancE

• Proprietary nanoFLEX™ Toric hydrophilic collamer® lens material has

a 50% higher water content than hydrophobic materials creating an

integrated Anti-Reflective layer and a visual clarity nearly equal to that of

the natural crystalline lens1

• 6 times fewer visually disturbing light reflections than certain hydrophobic acrylic lenses2

• nanoFLEX™ Toric hydrophilic Collamer® is free from glistenings and microvacuoles, a complication commonly associated with some

hydrophobic and hydrophilic acrylic IOL materials3,4

• improved contrast sensitivity and exceptionally sharp visual acuity by

equalizing spherical aberrations without compromising depth of field5

• c2 aspheric optic is designed to counterbalance decentration and tilt

using a curved retina model that most closely simulates in situ conditions6

ExcEllEnt rotational stability

• Dual haptic foramina allow fibrocellular tissue to migrate through and

around the lens hole to promote fixation to the equator of the capsular bag7

• Unlike C-loop haptic toric IOLs, nanoFLEX™ Toric IOL’s proven,

single-piece lens design is highly resistant to rotation8

postopEratiVE QuiEt EyE

• Due to the proprietary Collamer® material, nanoFLEX™ Toric significantly resists protein deposition9,10

• nanoFLEX™ Toric IOL, encapsulated by a monolayer of fibronectin, is rendered invisible to the body preventing the lens from being identified as

a foreign object9

controllED DEliVEry anD EasE of lEns positioning

• The nanoFLEX Toric lens has no recoil or rebound energy providing a

consistent and controlled delivery11

• Dual-Directional positioning design provides the ability to position the lens

in both a clockwise and counter clockwise direction for accurate alignment

nanoflEx™ toric iol with c2 aspheric optics and collamer® technology provides:

Aqueous AqueousLens Surface

Lens Surface

Inner lens

Acrylic lens

COLLAMER® lens

Natural crystalline lens

surgical pearls for successful outcomes

• Patient axis should be marked pre-op at the slit lamp, and sitting upright

• CCC should be in the range of 5.5 mm to 6.5 mm in diameter

• Minimize BSS infusion of the anterior segment. Leave eye relatively and safely

soft to prevent IOL movement. Leaving the eye somewhat “softer” than usual

generally allows the capsular bag to collapse around the IOL more immediately

• Use a cohesive viscoelastic, compared to dispersive viscoelastics, these are

less likely to coat the IOL surface

• Remove viscoelastic trapped behind the IOL with irrigation-aspiration to

maximize posterior capsule-IOL surface contact

• Confirm lens orientation after I&A and after wound closure to ensure that the

nanoFLEX™ Toric IOL did not move

Steps Cohesive Dispersive

CCC • Easy to fill AC

• May lose OVD through wound

• Must completely fill AC

• Stays in AC

Phaco • Goes away with first vacuum • Stays on endothelium

• Particles can stick to endothelium

• Increased risk of burn

IOL Insertion • Easy to open/maintain bag

• Easy to remove OVD

• Hard to remove residual OVD

• If realignment is necessary, it should be done within the first two weeks after

implantation, prior to IOL fixation

• YAG-laser posterior capsulotomies should be delayed until at least 12 weeks

after implantation

• YAG-laser of Collamer® has been reported but the material nature of

Collamer® is a suitable match for the energy beam allowing the lens to

self-heal

• YAG power should be from 0.8mJ to 2.0mJ

The following Surgical Pearls are recommendations that come from surgeons who have experience implanting nanoFLEX™ Toric lenses, and we are providing them for your consideration.

preVize optimized nanoflEx™ toric iol calculation software

• Creates a surgical worksheet that

includes preoperative data

• List of suggested surgical powers

(The choice of the lens selection

is yours)

• Clearly labeled illustration of

the exact placement of the

nanoFLEX™ Toric IOL

• To ensure that the power of the

cylindrical correction is maximized,

use the two markings indicating

the axis of the cylindrical correction

of the lens and align them with

the steep corneal meridian

nanoflEx™ toric iol calculator required data

• Steep K reading

• Steep K meridian/axis

• Flat K reading

• Flat K meridian/axis

• Surgically induced astigmatism (SIA) estimate

• Incision site

nanoflEx™ toric iol calculator is Designed to Help optimize your preop planning and lens power selection

5%

10%

19%

31%

2% 1% 1% 0% 0% 0%

30%

0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0

1.5 D to 3.5 D ≈ 20%

prevalence of astigmatism in the Eu population

nanoflEx™ toric iol cylinder power options

SOURCE: COMPREHENSIVE REPORT ON THE GLOBAL IOL MARkET BY MARkET SCOPE (MAY 2012)

Lens Model CC4204T

Cyl Power

IOL Plane 1.00 D 1.50 D 2.00 D 2.50 D 3.00 D 3.50 D 4.00 D

Corneal Plane 0.69 D 1.03 D 1.30 D 1.73 D 2.06 D 2.40 D 2.74 D

Recommended Corneal Astigmatism Correction Range

0.50 - 0.75 D 0.75 - 1.50 D 1.55 - 1.75 D 1.75 - 2.25 D 2.00 - 2.75 D 2.75 - 3.25 D 2.75 - 3.62 D

CC4204T

Optic Characteristics

Powers Diopter Cylinder

10.5 D to 30.5 D (0.5 D Increments)

1 D to 4 D (0.5 D Increments)

Shape 6.0 mm Biconvex Aspheric Toric

Material Hydrophilic Collamer®

Refractive Index 1.442

Biometry

A-Constant 118.6 (Suggested)

ACD 5.32

Haptic Characteristics

Overall Length 10.8 mm

Material Hydrophilic Collamer®

Foramina Diameter 0.9 mm

Style Single-Piece

©2013 STAAR Surgical Company10-0007-62 Rev A

STAAR Surgical AGHauptstrasse 104 CH - 2560 Nidau / Switzerland

0344

For more information, please visit www.staar.com or contact STAAR Customer Service at customerservice@staarag.ch.

Important Safety Information for nanoFLEX Toric IOL

INDICATIONS: The Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lenses are intended to correct aphakia and decrease refractive cylinder resulting from corneal astigmatism in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy). PRECAUTIONS: 1. Do not attempt to re-sterilize the Collamer 1P Toric IOL by any method as this can produce undesirable side effects. 2. Do not store the IOL in direct sunlight or at a temperature greater than 40°C. 3. Use only sterile intraocular irrigating solutions (e.g., balanced salt or normal saline solution) to rinse and/or soak IOLs. 4. The IOL may take up to 24 hours to reach its final optical power when in situ. 5. IOL rotation requiring less than 30° may not warrant reorientation. 6. Any reorientation should be performed prior to IOL fixation, generally within the first two weeks.

WARNINGS: 1. This Collamer 1P Toric IOL should not be implanted if the posterior capsule is ruptured or if a primary posterior capsulotomy is to be performed. 2. Since the study of the Model CC4203VF IOL was conducted with the IOL being implanted in the capsular bag only, there is insufficient clinical data to demonstrate its safety and efficacy for placement in the ciliary sulcus. 3. Physi-cians considering the Collamer 1P Toric IOL implantation under any of the following circumstances should weigh the potential risk/benefit ratio: a. Recurrent severe anterior or posterior segment inflammation or uveitis. b. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment disease. c. Surgical difficulties at the time of cataract extraction which might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pres-sure, or significant vitreous prolapse or loss). d. Non-sight threatening adverse events have been observed at the time of cataract surgery, which includes posterior capsule tear, anterior vitrectomy, incision enlargement, and corneal suturing. e. Previous trauma or developmental defect of an eye in which appropriate support of the IOL is not possible. f. Circumstances that would result in damage to the endothelium during implantation. g. Suspected microbial infection. h. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support. i. Children under the age of 18 are not suitable candidates for intraocular lenses. j. One or more iridectomies at the time of Collamer 1P Toric IOL implantation may prevent the need for secondary iridectomies for pupillary block. k. Existence of corneal endothelial dystrophy, glaucoma, active chronic anterior or posterior uveitis, rubeosis iridis, synechiae and short anterior segment. 4. Refractive change toward hyperopia (that may be successfully relieved by anterior YAG capsulotomy) has occurred in a small number of cases potentially due to posterior displacement of the IOL/capsular fibrosis. (Not reported when larger than 5.5 mm diameter capsulorhexis performed.) 5. YAG-laser posterior capsulotomies should be delayed until at least 12 weeks after the implant surgery. The posterior capsulotomy opening should be kept as small as possible. There is an increased risk of IOL dislocation and/or secondary surgical reintervention with early or large Posterior capsulotomies. 6. Physi-cians considering IOL implantation in patients with senile macular or retinal degeneration should be aware that the patient may not achieve any improvement in central visual acuity following intraocular lens implantation. 7. The safety and effectiveness of this IOL if placed in the anterior chamber have not been established. 8. The effectiveness of UV absorbing IOLs in reducing the incidence of retinal disorders has not been established. 9. STAAR Surgical Collamer® 1P Toric IOLs are packaged and sterilized for single use only. Cleaning, refurbishing and/or re-sterilization of these devices are prohibited to prevent contamination which could result in endophthalmitis and inflammation. 10. Do not attempt to re-sterilize or repackage the IOL. Do not autoclave the IOL. Do not freeze. Do not expose to temperature greater than 40°C. If temperature requirements are not met, return IOL to STAAR Surgical Company. 11. Patients who have had previous corneal refractive surgery may not accurately achieve the intended target refraction. 12. Do not use IOL if package has been opened or damaged. The sterility of the IOL may have been compromised.

ATTENTION: Reference the Directions for Use labeling for a complete listing of adverse events which may include iritis and corneal edema.

References

1. Gontijo I, The Collamer Story. 2006. Data on file. STAAR Surgical, Monrovia, Calfornia.

2. Ossipov A. Comparison of internal reflectance patterns of COLLAMER®, acrylic, and silicone. 1997. Data on file, STAAR Surgical.

3. Fry LL. Incidence of Glistenings in AcrySof IOLs. Presented at: American Society of Cataract and Refractive Surgery (ASCRS); April 3-8, 2009; San Francisco, Ca.

4. Apple DJ. Clinicopathological Study of the Importance Glistenings That Accumulate in the Optic of the AcrySof IOL. Presented at: American Society of Cataract and Refractive Surgery (ASCRS); April 3-8, 2009; San Francisco, Ca.

5. Data on file. STAAR Surgical, Monrovia, Calfornia.

6. Huang IP, Clinch TE, Moshafar M, et al. Decentration of 3-Piece vs Plate Haptic Silicone Intraocular Lenses. J Cataract Refract Surg. 1998;24:1505-1508.

7. Apple DJ, Werner L. Experts share in-sights on IOL choice ; The best design is yet to come, Ocular Surgery News. 2002.

8. Alio, J. L., et al. (2013) Clinical and optical intraocular performance of rotationally asymmetric multifocal IOL plate-haptic design versus C-loop haptic design; Jour-nal of Refractive Surgery. 29(4); 252-59.

9. Till JS. Collamer intraocular lens implanta-tion with active uvetis. J Cataract Refract Surg. 2003;2439-2443.

10. Fine IH. Aiming for a New Level of Bio-compatibility. Ophthalmology Manage-ment Supplement. May 2000;6S-7S.

11. Bylsma S. Foldable intraocular implant is gentle to patient’s eye. Ophthalmology Times. 2001:26(4).