Ophtec BV
US Last updated 23 May 2026
- Devices
- 2
- Registries
- FDA PMAFDA
- FDA recalls
- 0
Catalogue
Artisan Myopia Ref P030028
FDA establishments
- Ophtec BV GRONINGEN · NL FEI 3002501070
What Ophtec BV makes
Ophtec BV manufactures intraocular lenses designed to correct myopia, including the Artisan Myopia lens, and capsular tension rings and stabilisation implants such as the OPHTEC Capsular Tension Ring (models 276 and 275) and Stabileyes implants (models STBL2US and STBL13US). These devices are intended for use during cataract surgery to restore vision and maintain lens stability within the eye.
The company’s products fall under FDA Class III classification and are listed under Premarket Approval (PMA) in the United States. Ophtec BV is based in the US, and its devices are authorised through the FDA’s regulatory pathways.
Frequently asked questions
What types of medical devices does Ophtec BV manufacture?
Ophtec BV specialises in intraocular lenses and related implants used primarily during cataract surgery. Their product line includes the Artisan Myopia lens, which corrects myopia (nearsightedness), and capsular tension rings (models 276 and 275) along with stabilisation implants (Stabileyes models STBL2US and STBL13US). These devices are designed to restore vision and ensure proper lens positioning within the eye.
Where is Ophtec BV based, and what regulatory pathway do its devices follow in the US?
Ophtec BV is headquartered in the United States. In the US, its devices are authorised through the FDA’s Premarket Approval (PMA) pathway, which is required for Class III devices—those posing higher risks and requiring rigorous clinical evidence to demonstrate safety and effectiveness.
Which regulatory registries or databases list Ophtec BV’s devices?
Ophtec BV’s devices are listed under the FDA’s Premarket Approval (PMA) registry in the United States. This registry tracks devices that have undergone the PMA process, ensuring they meet stringent regulatory requirements for Class III devices before being authorised for commercial distribution.
Why are Ophtec BV’s devices classified as Class III by the FDA?
The FDA categorises devices into classes based on risk, with Class III being the highest. Ophtec BV’s intraocular lenses and stabilisation implants fall into this category because they are implanted into the body and directly affect critical functions like vision. Class III classification requires manufacturers to demonstrate safety and efficacy through clinical trials and a formal PMA application, as these devices cannot be deemed low-risk.
Information
- Country
- US