#Greece #CE Certification #EYE PCR #fixOflex #Heraklion

EYE PCR Achieves CE Mark for fixOflex Endocapsular Device

EYE PCR, a pioneer in ophthalmic technologies, has recently announced that its innovative endocapsular device, fixOflex, has received CE certification in accordance with the European Medical Device Regulation (EU MDR 2017/745). This significant achievement not only affirms the safety and efficacy of the device but also paves the way for its marketing in Europe and other CE-recognized markets.

A Breakthrough in Cataract Surgery

The development of fixOflex has been led by Professor Ioannis Pallikaris, whose team has spent over 15 years researching and refining the device. The aim of fixOflex is to maintain the shape of the capsular sac and the intracoastal space during and after cataract surgery, thereby optimizing the optical performance that surgeons strive to achieve for their patients.

According to Professor Pallikaris, "For more than fifteen years, our team has been dedicated to tackling one of the greatest challenges in cataract surgery: preserving the shape of the capsular sac after lens removal. FixOflex is engineered to maintain this shape while enhancing the optical outcomes for patients. The CE marking of our device is a crucial milestone, and we are committed to expanding the availability of fixOflex technology worldwide. We look forward to sharing more developments as our production and distribution plans are finalized."

Clinical Validation

Clinical evidence supporting fixOflex's efficacy comes from a prospective study involving 121 patients, which demonstrated that fixOflex offers a comparable safety profile to standard cataract surgery. Remarkably, the study showed a posterior capsule opacification (PCO) incidence of just 0.83% after 12 months—significantly lower than the 13% reported in a retrospective control group. Furthermore, none of the patients using fixOflex required Nd:YAG laser capsulotomy, whereas three patients from the control group did.

Understanding PCO

PCO, known as one of the most common complications following cataract surgery, can lead to visual impairment and typically requires additional surgical intervention, namely Nd:YAG laser capsulotomy, to restore clear vision. Literature reports PCO incidence rates of at least 11.8% after one year, highlighting the importance of innovation in this area. FixOflex is designed to act as a barrier, preventing the migration of lens epithelial cells that contribute to PCO.

About EYE PCR

EYE PCR leverages scientifically backed innovations to address some of the most pressing challenges in ophthalmology. Founded by Professor Ioannis Pallikaris, the company builds on decades of pioneering work in cataract and refractive surgery. Headquartered in Amsterdam, the organizational and clinical undertakings are centered in Heraklion, Greece.

For further information, please visit eyepcr.com or follow EYE PCR on LinkedIn.

Media Contacts

• - Sales / Market Inquiries: Fenia Pervolaraki - [email protected]
• - Investor Relations: Aristofanis Pallikaris - [email protected]
• - General Information: Elena Ioannou - [email protected]

This product is intended for professional use only. Indications, contraindications, and warnings are detailed in the product's instructions for use (IFU). fixOflex is a registered product of EYE PCR B.V.

Sources:

• - Pallikaris IG, et al. Safety and Efficacy of a New Endocapsular Device for Age-related Cataract Surgery: 12-month Follow-up. Transl Vis Sci Technol. 2026;15(2):8.
• - Horn JD, et al. Academy IRIS® Registry Analysis of Incidence of Laser Capsulotomy Due to PCO After Intraocular Lens Implantation. Clin Ophthalmol. 2022;161721-1730.
• - Konopińska J, et al. PCO: A Review of Experimental Studies. J Clin Med. 2021;10(13):2847.