FINEVISION HP Toric Brochure

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FINEVISION HP

Trifocal Hydrophobic IOL

THE STAR TREATMENT

FINEVISION HP & HP TORIC bvimedical.com


FINEVISION HP & HP TORIC the evolution of the original FINE trifocal technology
that reduce the burden of spectacle, offering continuous vision to accomplish any
task at all distances1 with the advantages of the GFY hydrophobic raw material.

Distance Intermediate Near

Optical Bench
Optimized near POD F GF: MTF50 Curve at 3,0mm aperture2
vision 0,5
Highest energy split pushed 0,45
0,4
to near vision without
0,35
compromising distance.
MTF50/mm

0,3
0,25
Quadrifocal lens vs
0,2
FINEVISION HP MTF50
0,15
curve @ 3mm aperture 0,1
0,05
0
Optimized range MTF 3 mm Quadrifocal lens MTF 3 mm FINEVISION
of vision
With two complementing add
powers (3.5D & 1.75D) - the
Clinical Evaluation
FINEVISION HP is creating a
POD F GF: Binocular Defocus Curve (D), photopic, 6 months2
smooth, balanced and harmonized
performance transition from -0.2
distance to near; whatever the -0.1
0
intermediate distance you are
VA [logMAR]

0.1
considering (66cm or 80cm), the 0.2
VA performance is higher than 0.3
0.1 logMar from -2.5D to -1.5D on 0.4
0.5
defocus curve. Photopic Defocus 6 months - Binocular, N-55
0.6
0.7
1 0.5 0 -0.5 -1 -1.5 -2 -2.5 -3 -3.5
Defocus [D]

What patients say ?


Do you still depend on glasses after FINEVISION treatment? (n=5,802 patients)

100%

80%
95% of patients reach
60%
complete spectacle
Patients

99% 98% 95%


independence at all distances.
40%

97% of patients treated with 20%

FINEVISION would choose


0%
the same IOL again!1 Distance Intermediate Near
CoPODize™ technology
The first and only optic that uses CoPODize technology, that combines both Convolution and Apodization
concepts on the entire optic surface. This unique technology is optimized to work in harmony with the pupil -
managing the risk of halo and glare when transitioning to mesopic conditions.

Hydrophobic raw material (GFY)


The IOL must withstand the test of time for the life of the patient. Glistenings have been a known phenomena
for hydrophobic IOLs, forming over time following implantation, which can impact the quality of vision.3
GFY hydrophobic material is unique to BVI. Accelerated age testing at David J. Apple Laboratory
demonstrated that GFY material is glistening free. 4,5,6

Simulation of the accelerated ageing in vitro glistening formation7


50
The GFY raw material is a
Grade 0 based on the Miyata
Microvacuoles (MV)/mm2

40
glistening scale (in vitro) 4, 5, 6

30
No significant difference in
GFY hydrophobic
material microvacuoles formation was
44.05
20
observed with the GFY material
compared to the hydrophilic
10 reference material (in vitro).8

7.01
4.47
0
GFY Hydrophilic Hydrophobic
reference reference Hydrophobic raw
material material material

What are the patient's benefits


"The GFY material showed its
effectiveness in the absence Over a million GFY IOLs have been implanted since it first use in 2010 and a clinical
of glistening. This survival study9 showed no glistenings after a 3 year follow-up. Within this publication, a
analysis shows no glistening rate of 2.3% of YAG capsulotomy was recorded over a 3 years period.
event during 36 months
follow-up."9
Survival analysis
1.00
0.90
Survival probability

0.80
0.70
0.60 n = 66 eyes
0.50
GFY
Hydrophobic
"One YAG has been made in 0.00 reference material

the GFY IOL cohort after the 0 12 24 36


Months
third year (n = 43 eyes)." 9
Give every patient’s eyes the star treatment

Unique haptic design for Toric version


POD platform is designed with a unique double C-loop haptics
configuration for excellent fixation within the capsular bag, with
an increased contact angle12 as well as 4-point contact versus
conventional C-loop designs. This platform is designed to:
• Allow for even distribution of the compression forces at the haptic-
capsular bag junction10
• Maintain low tilt and axial displacement11
• Provide excellent centration and rotation stability11
POD haptic
platform has 70%
greater contact angle vs
C-loop IOL platform12

POD platform with

Over
8 years 1.75° 1.85°

of experience with IOLs, providing POD L GF - Absolute postoperative IOL


reliability in terms of clinical outcomes13 axis rotation (°) at 4-6 months compared
to the day of surgery.14

BVI toric calculator has been developed to account the posterior corneal curvature by
creating an indirect benefits on the postoperative astigmatic patient outcomes.15

Go to Physioltoric.eu

"Easy control during the procedure"16


(Classic C-loop can only rotate clockwise)

Rotation to align the IOL cylinder, either


clockwise OR counter-clockwise reducing
the risk of misalignment.
Easy placement is
MANEUVERABILITY
Unique RidgeTech technology reduces
the risk17 of sticky haptics on the optics
during and after injection.
Medicel Accuject injector guidelines with POD platform
This fully single-use system represents reliable and effective lens injections with POD platform.
Their compact design with integrated cartridge enables predictable loading and positioning of the lens.

Guidelines steps with Accuject:

1 2 3

4 5 6

1. Apply ophthalmic viscoelastic device (OVD) into the tip and the loading chamber of the injector cartridge.
2. Remove the lens from the lens holder. Position the lens into the cartridge in such way that the two haptics with the notches are pointing
at 1 and 7 o’clock.
3. Exert slight pressure onto the lens optic and make sure that all haptics are inside before further closing the cartridge. Close the cartridge
and check the position of the lens.
4. Once the “click-lock“ mechanism engages, the lens is securely loaded and ready for injection.
5. Press the injector plunger forward and push the lens into the conical tip of the cartridge.
6. Pull the plunger back a few millimeters and then inject the lens in one continuous motion. For gentle implantation, it is not necessary to
fully push the plunger to the bottom of the cartridge.

1
R. Bilbao-Calabuig, MD et al.: Visual outcomes following bilateral implantation of two diffractive trifocal intraocular lenses in 10,084 eyes, American Journal of Ophthalmology, July 2017. |
2
MDR CER Report: RA_302_1_2021_144 Clinical Evaluation | 3 E. DeHoog, PhD, A. Doraiswamy, PhD: Evaluation of the impact of light scatter from glistenings in pseudophakic eyes, J Cataract
Refract Surg 2014; 40:95–103. | 4 Miyata A, Jpn J Ophthalmol 2001, 45(6):564-569. | 5 https://www.eurotimes.org/capsular-bag-stability-findl | 6 CER F2 (MIC-GFY) | RD-REP-210-1-2021 | V1.0 |
27.04.2021 | 7 Biomaterial Optical Purity. The David J Apple International Laboratory for Ocular Pathology, 3 MAY 2017 | 8 Biomaterial Optical Purity Report & Appendix 1, G.U. Auffarth, University
Hospital Heidelberg, May 2017. | 9 C. Chassain, France Journal of Ophthalmology (2018) 41, 513—520 | 10 POD T 49P mechanical properties 11979-3 (RD-REP-19-09Sv02). | 11 Draschl P, J Cataract
Refract Surg 2017, 43(2):234-238. | 12 Mechanical properties according to 11979-3 of Double C Loop (ID: 99B8EB20-C5D6-418E-A4DA-348E1114C396) | 13 Periodic Clinical Evaluation Report |
14
Clinical Evaluation Report POD-GFY, Family 1 ID: 287C9C9A-A937-4CC3-AC3F-06FE3D432663 | 15 Abulafia A, Koch DD, J Cataract Refract Surg 2016, 42(5):663-671. | 16 Philipp J Ophthalmol
2014;39:67-72 | 17 Physiol Report 002, 9 nov 2012.
FINEVISION HP & HP TORIC
Description FINEVISION HP
Model POD F GF
Material GFY Hydrophobic Acrylic18
Overall diameter 11.40mm
Optic diameter 6.00mm
Optic Biconvex Aspheric Trifocal
Haptic design POD (Double-C-loop) with Ridgetech® & Posterior Angulated Haptic
Filtration UV & Blue Light
Refractive index 1.53
Abbe number 42
Additional power (IOL plane) +1.75D & +3.50D
Injection system Medicel Accuject 2.0 up to 24.5D - Medicel Accuject 2.1/2.2 up to 35D
Spherical power +10D to +35D (0.5D steps)
Interferometry
Hoffer Q: pACD 5.85
Suggested Holladay 1: Sf 2.06
A constant19
Barrett: LF 2.09
SRK/T: A 119.40
Haigis20: a0; a1; a2 1.70; 0.4; 0.1
18
The PhysIOL GFY® is patented since 2010. Patent number: EP1830898. | 19 Values estimated only: surgeons are recommended to personalize their A-constant based on
their surgical techniques and equipment, experience with the lens model and postoperative results. | 20 Not optimized.

Description FINEVISION HP TORIC


Model POD FT 49P
Material GFY Hydrophobic Acrylic18
Overall diameter 11.40mm
Optic diameter 6.00mm
Optic Biconvex Aspheric Toric Trifocal
Haptic design POD (Double-C-loop) with Ridgetech® & Posterior Angulated Haptic
Filtration UV & Blue Light
Refractive index 1.53
Abbe number 42
Additional power (IOL plane) +1.75D & +3.50D
Injection system Medicel Accuject 2.1/2.2
Spherical power +10D to +35D (0.5D steps)
Cylinder power (IOL plane)21 1.00 - 1.50 - 2.25 - 3.00 - 3.75 - 4.50 - 5.25 - 6.00D
Suggested A Interferometry
constant19 Hoffer Q: pACD 5.85
Holladay 1: Sf 2.06
Barrett: LF 2.09
SRK/T: A 119.40
Haigis20: a0; a1; a2 1.70; 0.4; 0.1
POD FT 49P 1.0 POD FT 49P 1.5 POD FT 49P 2.25 POD FT 49P 3.0 POD FT 49P 3.75 POD FT 49P 4.5 POD FT 49P 5.25 POD FT 49P 6.0
Cylinder power at IOL plane 1.00D 1.50D 2.25D 3.00D 3.75D 4.50D 5.25D 6.00D
Cylinder power at 0.68D 1.03D 1.55D 2.06D 2.57D 3.08D 3.60D 4.11D
corneal plane22
The PhysIOL GFY® is patented since 2010. Patent number: EP1830898. | 19 Values estimated only: surgeons are recommended to personalize their A-constant based on their
18

surgical techniques and equipment, experience with the lens model and postoperative results. | 20 Not optimized. | 21 Please read the directions for Use for important safety infor-
mation and consult our specialists on the spherical and cylinder powers availability. | 22 Savini G., J Cataract Refract Surg 2013; 39:1900 –1903.

Please check the availability of the products on your market with your sales representative.

Contact Information: www.bvimedical.com/customer-support/


Manufacturer: PhysIOL s.a. - Liège Science Park - Allée des Noisetiers 4 - B-4031 - Belgium
+32 4 361 05 49 - physiol@bvimedical.com
Content last reviewed 02/2020

BVI and all other trademarks (unless noted otherwise) are property of BVI. BVI ©2022 1581271-02

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