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

Alcon GPS WaveLight GmbH, in collaboration with Alcon (China) Ophthalmic Products Co., Ltd., initiated a Class III voluntary recall of its VERION Ophthalmic Biometry and Surgical Planning System, as reported by the National Medical Products Administration (NMPA) on July 7, 2016. The recall addresses a critical software issue where unexpected curved incisions appear on printed, saved (.pdf), or exported surgical plans. This anomaly specifically impacts surgical planning for non-Alcon TORIC intraocular lenses (IOLs) when the VERION system is integrated with the Alcon LenSx laser system. The error is triggered if a user inadvertently activates the 'IOL 100% - RI 0%' slider, creating an added arc that is not visible on the system's graphical interface but only on the final output. This could lead to an overcorrection of astigmatism, potentially reducing visual acuity.

To correct this, users must ensure the 'IOL 100% - RI 0%' slider arrow is clicked before exporting, saving, or printing plans for non-Alcon Toric IOLs. It is crucial to verify that no unexpected curves are present on the final output or on the Digital Marker L/LenSx display. If a curve appears, the plan must be reopened, the slider reactivated, and the process repeated. Surgical plans for Alcon IOLs and non-Alcon non-Toric IOLs are unaffected and do not require special action.