Vietnam MOH registration 2403345ĐKLH/BYT-HTTB
Artificial crystalline lens
VN: Thủy tinh thể nhân tạo
Vietnam·Risk Class TTBYT Loại C·Clareon™ PanOptix™ Toric Trifocal Hydrophobic IOL·Registered Nov 06, 2024Registration details
- Analysis ID
- 2403345ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231207-0020
- Product Type
- Clareon™ PanOptix™ Toric Trifocal Hydrophobic IOL
- Product Code
- CNWTT3, CNWTT4, CNWTT5, CNWTT6
Company information
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ALCON PHARMACEUTICALS LTD TẠI HÀ NỘI
Technical details
- Intended Use
- 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)
Dates and status
- Registration Date
- Nov 06, 2024
Companies making similar products
Companies providing products similar to "Artificial crystalline lens"
Recent registrations
Recently registered similar products
Artificial crystalline lensNov 19, 2024
Manufacturer: PT. Ciba Vision Batam
Registration: 2403674ĐKLH/BYT-HTTB
Artificial crystalline lensNov 14, 2024
Manufacturer: Alcon Research, LLC
Registration: 2403513ĐKLH/BYT-HTTB
Artificial crystalline lensNov 14, 2024
Manufacturer: Eyeol UK Limited
Registration: 2403514ĐKLH/BYT-HTTB
Artificial crystalline lensNov 06, 2024
Manufacturer: HOYA Medical Singapore Pte.Ltd.,
Registration: 2403344ĐKLH/BYT-HTTB
Artificial crystalline lensNov 06, 2024
Manufacturer: Teleon Surgical B.V.
Registration: 2403370ĐKLH/BYT-HTTB
About this record
Access comprehensive regulatory information for Artificial crystalline lens in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403345ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ALCON PHARMACEUTICALS LTD TẠI HÀ NỘI.
This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, HOYA Medical Singapore Pte.Ltd.,, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI300,000+ Devices5 Competitors5 Recent Registrations