News 25-06-2024

Precizon & Artiflex MDR Compliant

By Ophtec

We are proud to announce our Precizon & Artiflex lenses will be delivered under the Medical Device Regulation (MDR) 2017/745 from as of August 1, 2024.

At Ophtec, we prioritize the quality and regulatory compliance of our products. Therefore, we are proud to announce that as of August 1, 2024, we will deliver the following Ophtec products under the Medical Device Regulation (MDR) 2017/745:

Product name Model (#) REF (Catalogue number)
Artiflex Myopia 40114SW 40114SW***
Artiflex Toric 4*0**SW 4*0**SW***
    Compatible with 
IOLMATIC Injector System
Non-compatible with IOLMATIC Injector System
Precizon Monofocal 560 56000TYP** / 56000TWP*** 56000TY** / 56000TW***
Precizon Toric 565 565**TYP** 565**TY**
Precizon Presbyopic NVA 570 570A1TYP** 570A1TY**
Precizon Presbyopic Toric 575 575A1**TYP** 575A1**TY**
Precizon Go 580 58000TYP*  

Our commitment to safety

The European MDR is one of the strictest regulations in the world, and achieving this compliance demonstrates our commitment to the highest safety standards for our products.

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