Eye PCR has received the CE Mark under the European Union Medical Device Regulation (EU MDR 2017/745) for its fixOflex endocapsular device, enabling commercialization in Europe and other CE-recognizing markets.

The certification supports the company’s planned controlled market introduction of the device, which is designed to preserve the capsular bag and maintain intracapsular space during and after cataract surgery. 

According to Eye PCR, fixOflex was developed over more than 15 years under the leadership of Ioannis Pallikaris, MD, PhD. The device is intended to maintain capsular bag configuration following lens removal and to optimize postoperative optical performance.

“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,” Dr. Pallikaris, founder of EYE PCR, said in a company statement. “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.”

The company has indicated that further details regarding production scale-up and distribution will be shared as plans are finalized.

Clinical support for the CE submission included a prospective study of 121 patients undergoing age-related cataract surgery with implantation of the fixOflex device.¹ At 12 months, posterior capsule opacification incidence was reported at 0.83%, compared with 13.0% in a retrospective control group.

No patients in the fixOflex group required Nd:YAG laser capsulotomy during the 12-month follow-up period, whereas three patients in the control group underwent capsulotomy.

Posterior capsule opacification remains one of the most common postoperative complications of cataract surgery. Published literature reports incidence rates of at least 11.8% at 1 year, and approximately 10% of patients may require Nd:YAG laser capsulotomy within the first postoperative year, depending on lens type and other factors.²

Eye PCR states that fixOflex is engineered to create a barrier to lens epithelial cell migration, a key mechanism in the development of posterior capsule opacification.

Further information is available at eyepcr.com.

References

1. Pallikaris IG, Elmassry A, Ginis HS, 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.

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.