FixOflex Endocapsular Ring Receives CE Mark for Enhanced Refractive Cataract Surgery Outcomes

HELSINKI — At the European Society of Cataract and Refractive Surgeons winter meeting, Ioannis Pallikaris, MD, PhD, announced that his fixOflex endocapsular ring received a CE mark under the EU Medical Device Regulation. Manufacturer Eye PCR said that the device will be commercially available soon to minimize risks and optimize outcomes of modern refractive cataract surgery.

FixOflex, an implantable ring made of hydrophilic acrylic, is designed to preserve the natural three-dimensional structure of the capsular bag after crystalline lens removal and to provide a stable bed for intraocular lenses (IOLs). By maintaining the capsular bag’s form, the device aims to reduce complications such as posterior capsular opacification (PCO), which remains one of the most common issues following cataract surgery.

Clinical evidence supporting the CE mark certification comes from a prospective study of 121 patients, which showed that fixOflex achieved comparable safety to standard cataract surgery with a PCO incidence of 0.83% at 12 months. This compares to a 13.0% PCO incidence in a retrospective control group. Notably, no patients in the fixOflex group required Nd:YAG laser capsulotomy, whereas three patients in the control group did.

The CE mark was obtained under the European Union Medical Device Regulation (EU MDR 2017/745), enabling commercialization across Europe and other markets that recognize the CE certification. This regulatory milestone validates the device’s safety and efficacy, positioning Eye PCR for controlled market introduction following more than fifteen years of research and refinement led by Professor Ioannis Pallikaris.

Posterior capsule opacification is frequently reported in literature, with incidence rates of at least 11.8% at one year post-surgery, and approximately 10% of patients requiring Nd:YAG capsulotomy to address visual impairment caused by lens epithelial cell migration. FixOflex is designed to create a barrier to this migration, thereby preserving both the structural integrity of the capsular bag and the optical performance surgeons aim to achieve for their patients.

Professor Ioannis Pallikaris, Founder of Eye PCR, stated: “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. 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.”

The device’s hydrophilic acrylic material contributes to its biocompatibility and stability within the eye, supporting long-term IOL positioning and reducing the risk of vitreous detachment. These combined effects are intended to enhance both the safety and refractive outcomes of cataract procedures.