China NMPA Product Recall - Soft contact lens

The National Medical Products Administration (NMPA) announced on May 28, 2021, a voluntary Class III recall initiated by CooperVision Inc., facilitated by its local affiliate CooperVision Products Trading (Shanghai) Co., Ltd. The recall pertains to specific models and batches of soft hydrophilic contact lenses, identified by Registration Certificate No.: 20153162423. The root cause for this action was a manufacturing anomaly involving the misalignment of tortuous surface markings on the affected products. This critical quality issue prompted CooperVision Inc. to proactively withdraw the compromised lenses from the market. This regulatory action, overseen by the NMPA, underscores the stringent quality and safety standards required for medical devices. The company's voluntary recall demonstrates its commitment to addressing product imperfections promptly, thereby ensuring product safety and maintaining consumer trust within the NMPA's comprehensive medical device regulatory framework. Additional specific details regarding the impacted product models and batches are available in the official "Medical Device Recall Event Report Form" published on the NMPA website.