fixOflex endocapsular device receives CE mark for treatment of patients after cataract surgery

EYE PCR has announced that fixOflex, its endocapsular device designed to preserve the capsular bag’s form and its intracapsular space during and after cataract surgery, has received CE mark certification from the European Union Medical Device Regulation (EU MDR 2017/745), enabling its commercialisation in Europe.¹

The certification was based on results from a prospective cohort study conducted in a university-affiliated private practice. During the study, patients were implanted with the fixOflex in 1 eye, the selection of which was randomised via a custom MATLAB algorithm. The device was implanted in the capsular bag in the presence of viscoelastic via a 2.4 mm injector through a standard capsulorhexis, before intraocular lens (IOL) implantation.²

“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,” Ioannis Pallikaris, MD, PhD, founder of EYE PCR, said in a statement. “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.”¹

Investigators for the trial enrolled participants who presented for standard cataract surgery in a university-affiliated private practice between December 2019 and June 2022. Patients were included if they had an age-related cataract with otherwise clear intraocular media, a nuclear cataract grade between N1 and N3 based on the Lens Opacities Classification System III and had no traumatic cataract or history of intraocular or corneal surgery, among other criteria. Patients were excluded if they had dense cataract, additional anterior segment pathology, or prior corneal surgeries, among other criteria.²

Among all eligible patients, every third patient who met the inclusion and exclusion criteria was prospectively enrolled in the experimental group. These patients were followed for ≥12 months post-operatively; investigators scheduled evaluations at 1 day, 1 week, and 1, 3, 6, and 12 months. At each visit, patients were given a full ophthalmic examination, measuring uncorrected and corrected distance visual acuity, refraction, intraocular pressure, optical biometry, and endothelial cell density.²

A total of 121 patients were enrolled in the trial, of whom 120 with a median cataract grade of N2 had no major protocol deviations and were incorporated into the analysis. Ultimately, 114 patients attended all study visits. The control group had a mean age of 68.33 +/- 7.53 years and a mean preoperative SE of -2.63 +/- 6.08 D. Compared to the experimental group, age was substantially higher (P <.05) while SE was similar (P = .34).²

A total of 16 adverse events were reported among 12 patients (9.9%), with the majority (56.3%) occurring in the right eye. The most common was macular oedema, of which 5 cases were classified as cystoid macula oedema, and the remaining 2 were mild, subclinical macular thickening. All adverse events resolved and were determined to be unrelated to the device.²

At 12 months, investigators recorded a posterior capsule opacification (PCO) incidence of 0.83% in the experimental group versus 13% in the control group. Additionally, mean corrected distance visual acuity and intraocular pressure were 0.03 +/- 0.07 logarithm of the minimal angle of resolution and 11.23 +/- 2.03 mmHg, respectively.²

Ultimately, the investigators determined that the new endocapsular device preserves posterior capsular transparency more effectively than other technologies, supporting IOL stability up to ≥12 months after the surgery. However, they emphasise that more data is needed to determine if A-constant adjustments or alternative IOL formulas are needed to provide refractive predictability, and to decide whether a supplementary device is needed to account for the anatomical interpatient variability of the lens.²

References

1. EYE PCR. EYE PCR Receives CE Mark for fixOflex Endocapsular Device, Enabling European Market Introduction. PR Newswire. 13 February 2026. Accessed 16 February 2026. https://www.prnewswire.com/news-releases/eye-pcr-receives-ce-mark-for-fixoflex-endocapsular-device-enabling-european-market-introduction-302684389.html

2. 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. Translational Vision Science & Technology. 2026;15(2):8. doi:10.1167/tvst.15.2.8