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.
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