EYE PCR’s fixOflex wins CE mark for EU rollout after strong PCO reduction data

CE clearance opens Europe for EYE PCR’s fixOflex endocapsular implant

HERAKLION, Greece — EYE PCR is moving to commercialise its fixOflex endocapsular device in Europe after receiving CE certification under the European Union Medical Device Regulation (EU MDR 2017/745), a regulatory milestone that validates the device’s safety and clinical profile and clears the way for a controlled market introduction. The CE mark enables sales across the EU and in other CE-recognising markets while obliging the company to maintain post-market surveillance and quality systems under EU MDR requirements. EYE PCR is finalising production and distribution plans as it prepares a phased roll-out and signals plans for further regulatory clearances in target geographies.

The device, developed over more than 15 years under Professor Ioannis Pallikaris, is designed to preserve capsular bag geometry and intracapsular space during and after cataract surgery to improve refractive stability and reduce posterior capsule opacification (PCO). Clinical evidence from a prospective study of 121 patients shows a PCO incidence of 0.83% at 12 months among fixOflex recipients versus 13.0% in a retrospective control group, with no fixOflex patients requiring Nd:YAG laser capsulotomy compared with three patients in the control cohort. EYE PCR presents these results as supporting the device’s safety and effectiveness relative to standard cataract surgery and as a driver for surgeon adoption.

With CE certification secured under EU MDR 2017/745, EYE PCR is prioritising investments in scale-up of manufacturing capacity, quality assurance and distribution channels to enable careful market entry. The company plans to collect real-world outcomes and engage in post-market clinical follow-up as part of ongoing compliance and to build the evidence base for broader uptake. EYE PCR also intends to use the CE mark to facilitate partnerships with hospitals and distributors while pursuing additional regulatory approvals for planned global expansion.

Regulatory obligations and next steps

Under EU MDR, EYE PCR must maintain active post-market surveillance, vigilance reporting and continued clinical evaluation; the company says it will meet those obligations and report further developments as production and distribution strategies are completed.

Clinical and inventor context

Professor Pallikaris, founder of EYE PCR and lead on fixOflex development, frames the device as addressing a central challenge in cataract surgery — preserving capsular pouch shape to stabilise optical outcomes — and the CE decision as a “key step” toward making that technology broadly available.