China NMPA Product Recall - Heparin-treated hydrophilic acrylic intraocular lenses

HexaVision SARL, in conjunction with its agent Beijing Millennium Golden Sail Pharmaceutical Technology Co., Ltd., initiated a voluntary Class III recall for its heparin-surface-treated hydrophilic acrylic intraocular lenses (CFDA (Imported) No. 20143220057) in China. This action, reported to the National Medical Products Administration (NMPA) on July 31, 2018, stemmed from findings during the 2017 national medical device sampling inspections. These inspections revealed two critical non-compliance issues: deviations in spectral transmittance and incorrect lens size. The affected products, identified under model HQ-201/HEP, are intended for posterior chamber implantation in cataract patients. The recall encompassed 3360 units across multiple batches, with 3287 units having been sold in China. Required actions included an immediate and proactive market recall of all affected product batches. HexaVision SARL was instructed to verify, rectify, and manage the non-compliant products to prevent recurrence. Furthermore, all recalled items are to be sealed and held for centralized destruction under the supervision of the Beijing Municipal Food and Drug Administration, ensuring adherence to regulatory standards.