# China NMPA Product Recall - Femtosecond laser corneal refractive surgery machine

Source: https://www.keypedia.com/records/china_product_recall/carl-zeiss-shanghai-management-co-ltd/6c65bbcc-27b7-4a77-93c4-a2cfd7d0d0d6
Source feed: China

> China NMPA product recall for Femtosecond laser corneal refractive surgery machine by Carl Zeiss (Shanghai) Management Co., Ltd. published February 26, 2019. Recall level: Level 2 Recall. Carl Zeiss (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for its femtosecond

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carl Zeiss (Shanghai) Management Co., Ltd. is voluntarily recalling its femtosecond laser corneal refractive surgery machine.
- Company Name: Carl Zeiss (Shanghai) Management Co., Ltd.
- Publication Date: 2019-02-26
- Product Name: Femtosecond laser corneal refractive surgery machine
- Recall Level: Level 2 Recall
- Recall Reason: Due to software version issues, in certain cases of aspiration failure, the treatment procedure may perform a corneal cap scan instead of creating a corneal flap. If the surgeon does not strictly follow the operating guidelines, there is a potential risk of corneal damage to the patient.
- 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 II recall for its femtosecond laser corneal refractive surgery machine, announced on February 26, 2019. The recall, overseen by the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration, addresses a software version issue within the SW-ReLEx (SMILE) application. Specifically, during the lenticule scanning phase of treatment, the device's software might erroneously perform a corneal cap scan instead of creating a corneal flap. While this software anomaly itself does not directly harm the patient, there is a potential for corneal damage if a surgeon fails to strictly adhere to operating guidelines when examining and attempting to lift the corneal flap after such an event. The company states that the probability of this aspiration loss event is extremely small, and to date, no reports of patient injury, serious harm, or death related to this software defect have been received. The company is taking required actions to address the issue, with details on affected product models and batch numbers available in the official "Medical Device Recall Event Report Form."

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