China NMPA Product Recall - Soft hydrophilic contact lens (trade name: Oculus FreshKon 1-Day (Etafilcon A) contact lens)

Shanghai FreshKon Contact Lens Co., Ltd. has initiated a voluntary Class III recall of its soft hydrophilic contact lenses, specifically the Oculus FreshKon 1-Day (Etafilcon A) product, following an announcement on July 5, 2019. This action was prompted by findings from a National Medical Products Administration (NMPA) sampling inspection. The inspection identified two significant quality control issues associated with batch number XE047018. Firstly, some contact lenses were found to be contaminated, raising concerns about product sterility and user safety. Secondly, the diameter of the affected lenses was measured at 14.45mm. This measurement exceeded the product’s specified range of 14.00mm to 14.40mm, indicating a failure to comply with the established product registration standards for dimensions. Under the regulatory oversight of the NMPA and the Shanghai Food and Drug Administration, Shanghai FreshKon Contact Lens Co., Ltd. is required to remove these non-compliant products from the market. A Class III recall is implemented when the use of, or exposure to, a violative product is not likely to cause adverse health consequences, yet the product does not meet regulatory requirements. The company's immediate action is to ensure all affected products, identified by their specific batch number, are withdrawn to uphold product integrity and consumer confidence in medical devices.