Artificial crystalline lens - Vietnam Registration 2403345ĐKLH/BYT-HTTB

Clareon™ PanOptix™ Toric Trifocal is indicated for use by trained ophthalmic surgeons. The artificial lens is indicated to be placed in the posterior capsule of the eye, replacing the natural lens of the person. This position allows the artificial lens to perform the function of the refractive medium in the eye, thus enabling the correction of vision by accommodation, as the lens is no longer present. The lens has a biconvex lens portion, with a non-spherical design that corrects for the positive spherical aberration of the cornea, as compared to a standard spherical lens. The refractive structure at the front surface divides the light to create a range of vision from distance to intermediate to near. This lens provides an additional option for ophthalmic surgeons to provide the patient with an additional +2.17 diopters of accommodation for intermediate vision and +3.25 diopters of accommodation for near vision. In addition, these lenses have an additional component of anisotropic refractive correction (toric) at the back surface of the lens, with a marked axis to help determine the more precise axis (the additional accommodation axis). This axis will be adjusted to match the marked axis pre-surgery, thus allowing the lens to correct any pre-existing anisotropic refractive error on the cornea. The effectiveness of the chromophore that filters green light in reducing the risk of macular degeneration has not been established. The amount of anisotropic refractive correction (toric) on the corneal surface for each code of the Clareon™ PanOptix™ Toric Trifocal lens is shown in Table 2. Table 2: Amount of toric correction and anisotropic refractive correction on the corneal surface for each code of the Clareon™ PanOptix™ Toric Trifocal lens Code: CNWTT3; Amount of toric correction at the surface of the lens: 1.50; Amount of toric correction at the surface of the cornea: 0.98/ Code: CNWTT4; Amount of toric correction at the surface of the lens: 2.25; Amount of toric correction at the surface of the cornea: 1.47/ Code: CNWTT5; Amount of toric correction at the surface of the lens: 3.00; Amount of toric correction at the surface of the cornea: 1.96/ Code: CNWTT6; Amount of toric correction at the surface of the lens: 3.75; Amount of toric correction at the surface of the cornea: 2.45/ (Amount of toric correction at the surface of the cornea: based on the average value of the human eye implanted with the Clareon™ PanOptix™ Toric Trifocal lens, using the SRK/T formula with a constant A of 119.1)