EYE PCR Receives CE Mark for fixOflex Endocapsular Device, Enabling European Market Introduction

EYE PCR Greece

CE Mark certification enables commercialization across Europe and other CE-recognizing marketsClinical evidence from a 121-patient prospective study supports device safety and efficacyCertification obtained under EU Medical Device Regulation 2017/745or follow EYE PCR on LinkedIn.

Media Contact:

Distribution / Sales / Market Inquiries:

Fenia Pervolaraki — [e-mail]

Aristofanis Pallikaris — [e-mail]

Investor Relations Opportunities:

Aristofanis Pallikaris — [e-mail]

Memet Yazici — [e-mail]

General Information:

Elena Ioannou — [e-mail]

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

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.15.2.8Horn 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.Konopi?ska J, M?ynarczyk 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.

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