China NMPA Product Recall - Soft hydrophilic contact mirror
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Shanghai Yuefeng Optical Technology Co., Ltd. initiated a voluntary Class III recall of its soft hydrophilic contact lenses on September 21, 2020. This action was primarily due to identified issues concerning incorrect product packaging labeling. The National Medical Products Administration (NMPA), specifically operating through the Shanghai Municipal Drug Administration, is overseeing this significant recall, which falls under China's comprehensive medical device regulatory framework. Although specific inspection dates are not detailed in this recall announcement, the company's proactive voluntary recall underscores its commitment to addressing compliance deficiencies. The main violation, incorrect labeling, is a critical concern as accurate product information is paramount for user safety and proper product application. The recall requires the company to remove affected soft hydrophilic contact lenses from circulation. Detailed information regarding the specific models, specifications, and batch numbers of the impacted products is provided in the "Medical Device Recall Event Report Form," which is accessible for all relevant stakeholders. This event highlights the ongoing importance of stringent quality control and strict adherence to labeling regulations within the medical device industry.
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