HERAKLION, Greece, Feb. 13, 2026 /PRNewswire/ -- EYE PCR announces that its fixOflex endocapsular device has received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745), enabling commercialization in Europe and other markets that recognize the CE Mark. This regulatory milestone validates the device's safety and efficacy, positioning EYE PCR for controlled market introduction.
Developed under the leadership of Professor Ioannis Pallikaris over more than fifteen years of research and refinement, fixOflex is designed to preserve the form of the capsular bag and its intracapsular space during and after cataract surgery and to optimise the optical performance surgeons aim to achieve for their patients.
"" said Professor Ioannis Pallikaris, Founder of EYE PCR. "."
A prospective study of 121 patients showed that fixOflex achieved comparable safety to standard cataract surgery with PCO incidence of 0.83% at 12 months, compared to 13.0% in a retrospective control group. No fixOflex patients required Nd:YAG laser capsulotomy, versus 3 patients in the control group.
PCO is one of the most common complications following cataract surgery, with literature reporting incidence rates of at least 11.8% at one year. PCO affects visual acuity and often requires Nd:YAG laser capsulotomy to restore clear vision with some 10% requiring Nd:YAG laser capsulotomy at one year postoperatively. fixOflex is designed to create a barrier to lens epithelial cell migration.
EYE PCR applies science-based innovation to address some of ophthalmology's most challenging issues. Founded by Professor Ioannis Pallikaris, the company builds on decades of pioneering research in cataract and refractive surgery. EYE PCR is headquartered in Amsterdam, The Netherlands, with research and clinical operations based in Heraklion, Greece.
For more information, visit or follow EYE PCR on LinkedIn.
Fenia Pervolaraki —
Aristofanis Pallikaris —
Aristofanis Pallikaris —
Memet Yazici —
Elena Ioannou —
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