China NMPA Product Recall - Soft hydrophilic contact lens (brand name: Colorful)

Bausch & Lomb Beijing Eye Care Products Co., Ltd. initiated a voluntary Class III recall of its "Colorful" brand Soft Hydrophilic Contact Lenses (CFDA Registration No. 20133221188). This action, publicized on February 23, 2016, followed findings from the National Medical Device Quality Bulletin dated December 22, 2015. The primary issue identified was a non-conformity in a specific product batch (B41001502, Posterior Vertex Power -1.00D). Testing revealed the refractive index to be 1.444, which exceeded the specified upper limit of 1.437 0.005. Despite this deviation, a company risk assessment concluded that the probability of harm to users was very low. Operating under the oversight of the National Medical Products Administration (NMPA), Bausch & Lomb proactively implemented the recall. The required actions included summarizing production, sales, and inventory data for the affected batch, as well as engaging distributors to manage existing stock. A total of 377 units were produced, with 322 units sold in China. This recall underscores the company's commitment to product quality and compliance with national medical device standards, even when potential risks are deemed minimal.