China NMPA Product Recall - Soft hydrophilic contact mirror

Qingdao Newbay Optical Manufacturing Co., Ltd. initiated a voluntary recall of specific batches (20180720, 20180719) of its Soft Hydrophilic Contact Lenses. This action was prompted by findings from a national unannounced inspection conducted by the National Medical Products Administration (NMPA). The primary issues identified in test reports included a critical lack of sterility in the lenses and the leakage of preservation solution from the product packaging. These serious quality control deficiencies pose potential safety risks and compromise the efficacy of the medical devices. Operating under the regulatory oversight of the NMPA, the company took proactive measures to remove the affected products from the market. The recall, referenced under NMPA Index No. JGXX-2018-11443 and publicized on December 10, 2018, underscores the importance of stringent manufacturing standards for medical devices. Further details regarding the specific models and specifications involved are documented in the associated "Medical Device Recall Event Report Form," indicating the company's commitment to addressing these deviations and ensuring patient safety.