# China NMPA Product Recall - Soft hydrophilic contact mirror

Source: https://www.globalkeysolutions.net/records/china_product_recall/bausch-lomb-incoporated/39fea943-0b33-44d2-956f-302780c3b002/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact mirror by Bausch & Lomb Incoporated published June 21, 2019. Recall level: Level 3 Recall. Bausch & Lomb Incorporated initiated a Class III voluntary recall for its soft hydrophilic contact l

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bausch & Lomb Incorporated is issuing a voluntary recall for its soft hydrophilic contact lenses.
- Company Name: Bausch & Lomb Incoporated
- Publication Date: 2019-06-21
- Product Name: Soft hydrophilic contact mirror
- Recall Level: Level 3 Recall
- Recall Reason: The instruction manual for this soft hydrophilic contact lens contains a typo; the correct refractive index value of 1.4036 was mistakenly written as 1.4306 and included in the product packaging.
- Discovering Company: Bausch & Lomb Eye Care Products Co., Ltd.
- Manufacturing Company: Bausch & Lomb Incoporated
- Summary: Bausch & Lomb Incorporated initiated a Class III voluntary recall for its soft hydrophilic contact lenses, as reported by the National Medical Products Administration (NMPA) on June 21, 2019. The recall stems from a typographical error in the product packaging and instruction manual, where the refractive index value was incorrectly listed as "1.4306" instead of the correct "1.4036". This issue affects products manufactured between January 2016 and August 2018, totaling 468,013 boxes sold in China. Despite the error, Bausch & Lomb clarified that the incorrect refractive index does not impact product fitting or consumer use, as this specific value is not utilized during these processes. The correct refractive index is documented in the product's registration certificate and technical requirements. To address the violation, Bausch & Lomb is required to promptly revise the instruction manuals for all newly manufactured soft hydrophilic contact lenses to display the correct refractive index of 1.4036. Furthermore, for the products already distributed, the company must issue a public warning to customers and consumers through its official China website (www.bausch.com.cn), informing them of the discrepancy and referring to the revised instruction manual if needed. Notably, this recall does not necessitate physical actions such as product replacement, physical recall, or relabeling, focusing instead on informational correction.

Company: https://www.globalkeysolutions.net/companies/bausch-lomb-incoporated/b12d8034-f316-4c4e-b374-fbd810ca9557/