MDR and Contact lenses retouching

The Medical Devices Regulation describes the roles and responsibilities of importers (Article 13) and distributors (Article 14). According to the regulations, manufacturers are responsible for their products once they have been placed on the market.

The distributors, in our case the contact lens practitioners, have to ensure as usual by means of representative random samples that the products they market comply with the regulations. They are also responsible for informing the manufacturers of complaints, reports and suspected incidents on their part and on the part of the contact lens wearer.

The deciding factor for contact lens reworking is that a product that has already been placed on the market can be adapted for a specific patient without changing its intended purpose. The fitter does not become the manufacturer and does not have to fulfill his obligations. If the contact lens specialist works on a lens even though the manufacturer forbids it, then in the event of a claim the specialist has to go to a social court. Each step of the contact lens post-processing must be noted in the customer file!

Possible adjustments of contact lenses by fitters

1. contact lens surface

• Removal of light scratches
• Removal of deposits

2. contact lens rim

• Rounding of the edge
• Removal of very small edge defects
• Thinning of the rim profile
• Widening the bevel
• Shifting the apex

3. changing refraction value

4. reduction of the diameter

The VDCO and Gustav Pöltner, Dipl.-Ing. (FH), head of the ophthalmic optics course at Health University of Applied Sciences Tyrol give an online seminar on contact lens post-processing. With photos and short videos, all the necessary steps are repeated, deepened and you learn what quickly leads to a good and comfortable wearing experience for the customer. Questions can be asked directly. Microphone and video are freely available for up to eight participants in the seminar, so that your individual concerns can be addressed at any time.