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

Bausch & Lomb Eye Care Products Co., Ltd. initiated a voluntary Class III recall of its 'Colorful' brand soft hydrophilic contact lenses. This action followed a December 22, 2015 National Medical Device Quality Bulletin, which highlighted a quality non-conformity in a specific product batch. The primary issue identified was that the refractive index test result for these lenses measured 1.444, exceeding the established upper limit requirement of 1.437\[plusmn]0.005. While Bausch & Lomb's risk assessment indicated a very small possibility of harm resulting from this deviation, the company proceeded with the recall in accordance with National Medical Products Administration (NMPA) guidelines. The Level 3 classification signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Concurrently, Beijing Boshi Products Co., Ltd. also announced a voluntary Class III recall for its 'Binbin' brand soft hydrophilic contact lenses (registration number: CFDA (Approval) No. 20133221188) due to unspecified reasons. Both companies are taking proactive measures to address quality issues under the regulatory oversight of the NMPA, ensuring product safety and compliance. Detailed information on affected products and batches is available in their respective Medical Device Recall Event Report Forms.