China NMPA Product Recall - VERION Ophthalmic Biometry and Surgical Planning System (Vision Planning System)

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Alcon GPS - WaveLight GmbH and its Chinese subsidiary, Alcon (China) Ophthalmic Products Co., Ltd., concerning the VERION Ophthalmic Biometry and Surgical Planning System (Registration No.: 20143226003). The recall, reported on April 20, 2016, and published May 19, 2016, addresses a critical software anomaly. The primary issue involves the unexpected appearance of curved incisions outside the intended surgical plan on printed, saved PDF, or exported surgical plans. This error specifically manifests when the VERION system is integrated with the Alcon LenSx laser system for planning procedures involving non-Alcon TORIC intraocular lenses. The anomaly occurs if a user inadvertently activates a "IOL 100% - RI 0%" slider in the software, which then incorporates an unnoted curved incision not visible on the system's graphical user interface. Proceeding with such a plan could lead to astigmatism overcorrection and reduced visual acuity. Affected users are required to take specific corrective actions. On the VERION system, before exporting, printing, or saving, users must click the "IOL RI 0%" slider arrow and verify that no arc appears on the output. If an arc is present, the interface must be reopened, the slider clicked again, and the plan re-exported/saved/printed. Similarly, on the Digital Marker L/LenSx Laser System, if an arc is visible, users must return to the VERION system for correction. These actions are only necessary when planning for non-Alcon Toric intraocular lenses.