Why a new Iol ? To integrate latest surgeons' requirements in terms of : Asphericity Protection against maculopathie

2. Why a new Iol ? • To integrate latest surgeons' requirements in terms of : • Asphericity • Protection against maculopathies • Perfect and stable axial positioning • Low PCO rate • Ease of handling and injection through small incision

3. In more details... • Bi-Flex has been developed taking into considerations that it should offer : • Animproved vision quality whilst retaining an excellent depth of field • Thepotential to opt for the natural yellow filter and thus respect the natural evolution of the crystalline lens • An adequate design to guarantee an implant centred with stable axial positioning immediately after surgery • An easy handling and injection whatever the surgical programme used (including operations where small-size incisions are used) • A pertinentmaterial for total biocompatibility with the ocular tissues and with greatly reduced post-operative inflammation rates.

4. What are the results? An intra-ocular lens with all the necessary qualities

5. The Bi-FLEX 677 AB Bi-FLEX 677 ABY

6. 4major assets for • Adapted design for optimised mechanical behaviour and optical quality • A material recognised throughout the profession • A “natural” yellow filter for better protection of the macula against the blue light • Aspheric implants to limit optical aberrations and improve the visual comfort of patients

7. Asset N°1Adapted design for optimised mechanical behaviour and optical quality • With: • A design suitable to standard surgical techniques (co-axial, bi-axial, micro-axial, etc.) enabling insertion through incisions of less than 2.2 mm, with no risk of tearing. • Excellent haptic compressibility toensure a perfect adaptability to the size of the bag • An aspheric optical design for implants immune to the usual defects in positioning such as decentration or tilting.

10. Zoom on design • The designs guaranteed by the Medicontur expertise and by its 20 years of experience : the design combines all the qualities of monobloc implants with those of 3-piece implants for: • Excellent stability • Optimised symphysis • Very limited capsular retraction • Complete ease-of-use

11. Zoom on the design • In detail: • A square edge over 360° for effective control of the development of PCO. • A real 6 mm optic size • Flat implant but with a posterior vaulting • Perfect contact zone with the capsulefor a stable implant in the plane and excellent refractive results.

12. Zoom on the Bi-Flex design • In detail: • (continuation) • Discontinuities on the optical diameter for Bi-Flex, positioned at 90°to each other to stabilise the optic, fix the implant against the capsule and have better control of post-operative rotation. • An optimised elbow-shaped bend for Bi-Flex, with a wide loop connection and a wider space (Dolphin zone) for increased stability, optimal flexion without overlap of the end of the loop on the optic and perfect symphysis with reduced risk of capsular retraction. • Blunt loop ends for Bi-Flex • for trauma-free insertion of the implant.

13. Zoom on design history • Comparison with the ACR6DSE • Comparison with IDEA

14. ACR6D-SE Corneal design in a flexible ring Note the approx. 60°contact angle and the decentralised IOL in the lower right. Near the tip of the loop there is an area of no contact.

15. ACR6D-SE Corneal design in a rigid ring 63° contact angle with simulation of rigid capsular sac of 9.0 mm diameter. Note that only the central part of the loops rests on the capsular equator.

16. Xcelens IDEA design in a rigid ring 74°contact angle with simulation of rigid capsular sac of 9.0 mm diameter. Note the good contact (homogeneous) of the loops with the capsular equator for their entire length.

17. Bi-FLEX Bi-Flex design in a rigid ring 91°contact angle with simulation of rigid capsular sac of 9.0 mm diameter. Note the good contact (homogeneous) of the loops with the capsular equator for their entire length. In total Bi-Flex has more than 180°contact angle with the capsular bag.

18. Bi-FLEX versus IDEA: in a flexible capsular bag simulation Bi-FLEX IDEA

19. Square edges ACR6D-SE versus ACR6D-SE: comparison SE The square-edges of the Flex range are perfectly sharp thanks to a new technology : the polish free method.

20. Ultimate stability Perfect and stable axial positioning

22. The Bi-Flex range is compatible with the MedJet injection system for incision sizes 2.2 mm and sub 2.0 mm

23. Asset n°2 A material recognised throughout the profession :the 25% Hydrophobic/Hydrophilic material

24. Asset N°2A material recognised throughout the profession : the 25% Hydrophobic/Hydrophilic material • To note: • Copolymer material (25%) combining hydrophobic and hydrophilic monomersfor additional properties. • Excellent pseudo-elasticity for the implants, due to the hydrophobic monomers. • Post-operative inflammation rate greatly reduced due to the hydrophilic monomers. • Implants totally compatible with the ocular tissues.

25. What is the winning combination? • 2-HEMA : 2-hydroxyethyl methalycrate A hydrophilic monomer • EOEMA : 2-ethoxyethyl methalycrate A hydrophobic monomer • To form a copolymer with: • Lower water content • Higher refractive index • Improved mechanical properties. • For improved mechanical properties : • superior pre-insertion folding capacities • post-insertion unfolding and optical properties perfect recovery.

26. Mixing hydrophily and hydrophoby 25% water content after combination of the two monomers, to form an highly biocompatible polymer • Medicontur foldable raw material : a combination of two monomers • HEMA, highly hydrophilic monomer • Pure HEMA = 38% water content • BIOCOMPATIBILITY • EOEMA, hydrophobic monomer • Approximately 2% water content • ELASTICAL PROPERTIES • SOFTNESS EOEMA 36% HEMA 64%

27. MMA Methylmetacrylate RAYNER B&L CORNEAL HEMA Hydroxyethylmetacrylate Rare IOLs in pure HEMA PALMLENS (CORNEAL) EOEMA Etoxyethylmetacrylate Flex range lens Comparison with other polymers : focus on the molecular scale The Flex range raw material specificity : the longest chain

28. Anti-PCO behaviour A long chain acts as a « molecular eyelash »to prevent cell adhesion and protein deposit Our raw material : low adhesion for a low PCO rate Apart from design, chain length has a proven effect against cell adhesion : Hydrogel MMA 26% Bi-Flex, Q-Flex, Z-Flex material

29. Soft and re-arrangeable innovative matrix A long chain of medium hydrophily :an essential specification for mini & micro cataract surgery pHEMA Hydrogel MMA 26% Bi-Flex material • Lower risk of tears with the Flex range than with HEMA thanks to a reduced hydrophily and the tensile strength of hydrophobic monomers • Much softer elasticity properties of the Flex range, 3 times better than MMA26% material Bi-Flex, Z-Flex & Q-Flex ’lens raw material : perfect for any kind of incision

30. What are the properties of the IOLs conferred by this material?

31. Asset n°3 A “natural” yellow filter for better protectionof the macula against the blue light

32. Asset N°3 A “natural” yellow filter for better protection of the macula against blue light • For: • Increasing the protection of the maculathe defence mechanisms of which change with age • Compensating the disappearance of the yellow pigment which has developed in the lens over the years, and which reinforces the protection of the retina against photo-toxic short waves. • Totally preserving colour vision and excellent contrast perception because the filtration does not interfere with the chromatic sensitivity of the retina.

33. Zoom on the compensation of the disappearance of the yellow pigment 1.The natural crystalline lens is replaced>> The “natural”  yellow filter barrier disappears 2.The macula does not benefit anymore from the “natural”  yellow filter barrier.Macula’s defense mechanisms are also altered with age.>> It is dangerously exposed to blue light. That is whyBi-FLEX677ABY, Q-FLEX640ABY, Z-FLEX690ABY include a protective filter adapted to these wave lengths.

34. Nature’s own solutions are the best… Why our Medicontur yellow filter is said to be “natural”? Because our material integrates the same UV-A blocking and violet light filtering chromophore that is in the human crystalline lens Why is Medicontur natural yellow filter superior? Because it protects the retina without blocking the required blue light. Medicontur natural yellow filter provides complete natural protection without making the retina losing its contrast sensitivity or colour perception.

35. Conclusion on Yellow natural filter The Medicontur’s approach aiming at protecting the retina from UV-A and violet light is based upon nature’s own solutions. Medicontur IOL material thus integrates the same UV-A blocking and violet light filtering chromophore that is in the human crystalline lens. The Medicontur natural Yellow filter is superior to any other yellow IOL material because it protects the retina without blocking the required blue light. It provided complete natural protection without making the retina loosing its contrast sensitivity or colour perception.

36. Asset n°4 Aspheric implants to limit optical aberrations andimprove the visual comfort of patients

37. Asset N°4 Aspheric implants to limit optical aberrations and improve the visual comfort of patients • With: • A neutral asphericity approach, which constitutes the best choice in case of unknown individual corneal aberration • The retention of the natural physiological aberrations of the cornea, mainly sphericity, to provide the patient with good quality vision and depth of field. • The recognition of the physiological ocular asymmetries (kappa angle) in the design of FLEX lenses to minimise the astigmatism and coma aberrations.

38. What is an aberration? • An aberration is an optical limitation that reduces image quality. • It usually results in a local or global blur. • It can also produce distortion or color trouble. • There are3main aberration types: • Chromatic aberration • Coma aberration • Spherical aberration

39. Chromatic aberration The image of a point is a circular spot with annular separated colors :yellow, red and blue

40. Coma aberration The image of a point is a comet-like spot :the image is blurry, particularly at the comet tail. The more tilted the lens is, the more aberrated

41. Spherical aberration The image of a point is a circular spot : the image is blurry. The more the power is or the bigger the pupil is, the more aberrated.

42. PHAKIC EYE : COMPENSATION EFFECT - + No SA or slighly + This compensation effect of the crystalline lens has been fully described in literature [9] PSEUDOPHAKIC EYE with SPHERICAL IOL : + + ++ SA Increased spherical aberrations

43. + + - NEUTRAL IOL CORRECTING IOL 0 + CURRENT ASPHERIC IOLS : 2 major approaches No spherical aberration Spherical aberration OUR APPROACH

44. Why to chose a neutral asphericity?Because : 1.The human eyes are naturally asymmetrical >> there is a benefit to have a lens not sensitive to tilt and decentration 2.Bi-Flex specific designs are optimized >> to minimize coma and astigmatism aberrations 3. While preservingnatural and physiologicalspherical aberrations of the cornea>>to improve depth of field.

45. • Flex IOLs •Spherical • Flex IOLs •Spherical The optical result in the eye With the image on the retina is the sharpest possible created by a single lens – not contributing to any pre-existing spherical aberration in the eye.

46. THE MEDICONTUR FUTURE