EYE PCR Earns CE Mark for its fixOflex Endocapsular Device

EYE PCR’s fixOflex endocapsular device has secured CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745), positioning the company for controlled market introduction.

Developed under the tutelage of professor Ioannis Pallikaris over more than 15 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 optimize the optical performance surgeons aim to achieve for their patients.

“For more than 15 years, our team has worked to address one of the persistent challenges in cataract surgery: preserving the form of the capsular bag after lens removal,” EYE PCR Founder Ioannis Pallikaris. “fixOflex was designed to preserve capsular form and optimize the optical performance that surgeons aim to achieve for their patients. CE marking of the device is an important step, and EYE PCR is planning to invest in global expansion of availability for the fixOflex technology. We look forward to sharing further developments as production and distribution plans are finalized.”

A prospective 121-patient study showed that fixOflex achieved comparable safety to standard cataract surgery with PCO incidence of 0.83% at 12 months, compared to 13% in a retrospective control group. No fixOflex patients required Nd:YAG laser capsulotomy, versus three patients in the control group.¹

PCO is one of the most common complications following cataract surgery, with literature reporting incidence rates of at least 11.8% at one year.² 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.³ 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. 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.

References
¹ Pallikaris IG, et al. Safety and efficacy of a new endocapsular device used in age-related cataract surgery: Twelve-month follow-up. Transl Vis Sci Technol. 2026;15(2):8, https://doi.org/10.1167/tvst.15.2.8
² Horn JD, Fisher BL, Terveen D, Fevrier H, Merchea M, Gu X. Academy IRIS® Registry Analysis of Incidence of Laser Capsulotomy Due to Posterior Capsule Opacification After Intraocular Lens Implantation. Clin Ophthalmol. 2022;16:1721-1730. https://doi.org/10.2147/OPTH.S358059.
³ Konopińska J, Młynarczyk M, Dmuchowska DA, Obuchowska I. Posterior Capsule Opacification: A Review of Experimental Studies. J Clin Med. 2021;10(13):2847. https://doi.org/10.3390/jcm10132847.