# China NMPA Product Recall - IOLMaster 700 Ophthalmic Optical Biometer

Source: https://www.globalkeysolutions.net/records/china_product_recall/carl-zeiss-shanghai-management-co-ltd/80c2d7ba-7988-4970-824b-844037a0805d/
Source feed: China

> China NMPA product recall for IOLMaster 700 Ophthalmic Optical Biometer by Carl Zeiss (Shanghai) Management Co., Ltd. published June 22, 2021. Recall level: Level 3 Recall. Carl Zeiss (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its IOLMaster 7

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carl Zeiss (Shanghai) Management Co., Ltd. is voluntarily recalling ophthalmic optical biometers.
- Company Name: Carl Zeiss (Shanghai) Management Co., Ltd.
- Publication Date: 2021-06-22
- Product Name: IOLMaster 700 Ophthalmic Optical Biometer
- Recall Level: Level 3 Recall
- Recall Reason: The manufacturing address in some Chinese instruction manuals for the IOLMaster 700 ophthalmic optical biometer is incorrectly printed as "Goeschwitzer Strasse 10, 07745 Jena, Germany". It should be printed as "Carl Zeiss Promenade 10, 07745 Jena, Germany".
- Discovering Company: Carl Zeiss (Shanghai) Management Co., Ltd.
- Manufacturing Company: Carl Zeiss (Shanghai) Management Co., Ltd.
- Summary: Carl Zeiss (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its IOLMaster 700 ophthalmic optical biometers, as reported by the National Medical Products Administration (NMPA) on June 22, 2021. This action was taken due to a printing error found in the Chinese instruction manual for the affected devices. The production address was incorrectly listed as "Goeschwitzer Strasse 10, 07745 Jena, Germany" instead of the accurate "Carl Zeiss Promenade 10, 07745 Jena, Germany." The recall operates under the regulatory oversight of the NMPA, referencing index No. JGXX-2021-10307 and Shanghai Municipal Drug Administration notice 沪药监械主石2021-119. Although the issue is a documentation inaccuracy rather than a product defect impacting performance or safety, Carl Zeiss (Shanghai) Management Co., Ltd. proactively implemented the recall to ensure the integrity and correctness of product information. The company has provided comprehensive details on the specific models, specifications, and batches involved in the "Medical Device Recall Event Report Form." This action underscores the company's commitment to regulatory compliance and accurate product documentation within the NMPA framework.

Company: https://www.globalkeysolutions.net/companies/carl-zeiss-shanghai-management-co-ltd/28dd2a9f-f4b7-460c-926f-218381eda9b1/