EYE PCR announces that its fixOflex endocapsular device has received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745), marking an important regulatory milestone in making a new option available to cataract and refractive surgeons in Europe.

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.

Clinical Evidence
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.

Posterior capsule opacification remains one of the most common complications following cataract surgery, with literature reporting incidence rates of at least 11.8% at one year with 10% requiring Nd:YAG capsulotomy. fixOflex is designed to address this by creating a barrier to lens epithelial cell migration.

Statement from Founder
"For more than fifteen 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," said Professor Ioannis Pallikaris, Founder of EYE PCR. "fixOflex was designed to preserve capsular form and optimise 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 finalised."

About EYE PCR
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.

Follow EYE PCR on LinkedIn.

Media Contact:
Distribution / Sales / Market Inquiries:
Fenia Pervolaraki — f.pervolaraki@eyepcr.com
Aristofanis Pallikaris — a.pallikaris@eyepcr.com
General Information:
Elena Ioannou — e.ioannou@eyepcr.com

*For professional use only. For indications, contraindications and warnings, please refer to the Instructions for Use (IFU). fixOflex is a registered product of EYE PCR B.V.*

References:
1. Pallikaris IG, et al. Safety and efficacy of a new endocapsular device used in age related cataract surgery: 12 months 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.