China NMPA Product Recall - Soft hydrophilic contact lens, 42% hioxifilcon A, 58% water content (spherical), daily disposable.

Kelibo (Shanghai) Optical Co., Ltd. initiated a voluntary Class III recall for its soft hydrophilic contact lenses, specifically the 42% hioxifilcon A, 58% water content (spherical) daily disposable variant. This action was reported on June 25, 2021, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The primary reason for the recall was identified as non-compliance with minimum sterile packaging labeling requirements, a critical issue for medical devices that could affect product identification and safe use. Such labeling deficiencies necessitate corrective action to uphold patient safety and regulatory standards. The recall impacts specific models, specifications, and batches, with detailed information available in an accompanying Medical Device Recall Event Report Form. This voluntary recall demonstrates the company's commitment to addressing product deficiencies in adherence to China's stringent medical product regulatory framework, ensuring the integrity and safety of medical devices in the market.