China NMPA Product Recall - Femtosecond laser corneal refractive surgery machine

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."