China NMPA Product Recall - L161AOR intraocular lens

Bausch & Lomb (Shanghai) Trading Co., Ltd. initiated a Level I voluntary recall for its LI61AOR model intraocular lenses following numerous complaints regarding pre-implantation fractures. The manufacturer, Bausch & Lomb Inc., identified the root cause as substandard materials. While the issue did not pose a risk of harm to patients during implantation, the defect warranted a high-level recall to prevent potential complications. The recall notification was received by Bausch & Lomb (Shanghai) on May 25, 2015, prompting immediate action. The company promptly organized an investigation, determined the affected quantities and distribution, and formulated a comprehensive recall plan. By May 26, all existing inventory of the affected lenses was sealed and quarantined. For products already distributed, efforts were launched to retrieve 1486 units sold in the Chinese market, with an anticipated completion by mid-June. The affected products are slated for destruction in accordance with national regulations by the end of June 2015. Overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration, this recall impacts markets including Australia, India, Malaysia, South Korea, and China. Regulatory bodies have instructed medical device operators and institutions to fully cooperate with Bausch & Lomb in this process and to proactively report any adverse events associated with the product.