#Greece #CE Mark #EYE PCR #fixOflex #Heraklion

EYE PCR's fixOflex Device Receives CE Mark Certification

EYE PCR has recently achieved a significant milestone by obtaining the CE Mark certification for their fixOflex endocapsular device, as reported on February 13, 2026. This certification, compliant with the EU Medical Device Regulation (MDR 2017/745), will allow for the device's commercial distribution across Europe and other regions recognizing the CE Mark.

The journey to this achievement has taken over fifteen years of dedicated research and development. Guided by Professor Ioannis Pallikaris, the fixOflex device has been engineered to maintain the configuration of the capsular bag and its intracapsular space during cataract surgery, as well as to enhance optical performance—a crucial aspect considered by ophthalmic surgeons for their patients.

Overview of fixOflex

The fixOflex device was specifically designed to tackle one of the persistent challenges in cataract surgery: the preservation of the capsular bag's form following the removal of the crystalline lens. Professor Pallikaris has stated, “For more than fifteen years, our team has worked to address one of the challenges in cataract surgery: preserving the shape of the capsular bag after the removal of the lens. The fixOflex device aims to achieve this and to optimize the optical performance sought by surgeons.”

This advancement marks a vital step for EYE PCR, which plans to invest in expanding the global accessibility of the fixOflex technology. The company looks forward to sharing more developments once the production and distribution plans are finalized.

Clinical Evidence Supporting fixOflex

A prospective study involving 121 patients indicates that fixOflex demonstrates a safety profile comparable to that of standard cataract surgery. The incidence of posterior capsule opacification (PCO) observed was a mere 0.83% at the 12-month mark, significantly lower than the 13% noted in a retrospective control group. Notably, no participants treated with fixOflex needed Nd:YAG laser capsulotomy, unlike three patients from the control group.

Understanding Posterior Capsule Opacification (PCO)

Posterior capsule opacification is among the most frequent complications stemming from cataract surgery, with an annual incidence rate of at least 11.8%. PCO impacts visual acuity and often necessitates Nd:YAG laser capsulotomy to restore clear vision. Remarkably, about 10% of all patients may require this procedure within a year post-operation. The design of fixOflex includes a barrier to prevent the migration of epithelial cells from the lens, thereby reducing the risk of PCO incidence.

About EYE PCR

Founded by Professor Ioannis Pallikaris, EYE PCR is committed to applying science-driven innovation to tackle some of ophthalmology's most intricate challenges. The roots of the organization lie in decades of pioneering research in cataract and refractive surgery. Headquartered in Amsterdam, Netherlands, the company conducts its clinical operations and research in Heraklion, Greece.

For more detailed information regarding EYE PCR and the fixOflex device, interested parties can visit their official website at eyepcr.com or follow EYE PCR on LinkedIn for the latest updates.