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

Source: https://www.globalkeysolutions.net/records/china_product_recall/alcon-gps-wavelight-gmbh/5c0f091a-badb-4a81-b6e9-ab683cafb097/
Source feed: China

> China NMPA product recall for VERION Ophthalmic Biometry and Surgical Planning System (Vision Planning System) by Alcon GPS WaveLight GmbH published May 19, 2016. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a recall notice regarding the VERION O

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Alcon GPS - WaveLight GmbH is proactively recalling the VERION ophthalmic biometry and surgical planning system (vision planning system).
- Company Name: Alcon GPS WaveLight GmbH
- Publication Date: 2016-05-19
- Product Name: VERION Ophthalmic Biometry and Surgical Planning System (Vision Planning System)
- Recall Level: Level 3 Recall
- Recall Reason: Unexpected curved incisions outside the surgical plan may occur in printed, saved (.pdf), or exported surgical plans. Curved incisions may appear in surgical plans if the user inadvertently activates the deactivated "IOL 100% - RI 0%" slider during the planning process.
- Discovering Company: Alcon (China) Ophthalmic Products Co., Ltd.
- Manufacturing Company: Alcon GPS WaveLight GmbH
- Summary: The National Medical Products Administration (NMPA) published a recall notice regarding the VERION Ophthalmic Biometry and Surgical Planning System, manufactured by Alcon GPS - WaveLight GmbH and distributed by Alcon (China) Ophthalmic Products Co., Ltd. This Class III voluntary recall, initiated on May 19, 2016, addresses a critical software issue affecting the system globally, with 27 units impacted in China. The regulatory framework for this recall is established by the NMPA.

The core problem involves the unexpected appearance of curved incisions on surgical plans when printed, saved as a PDF, or exported. This specific anomaly occurs only when the VERION system is used in conjunction with the Alcon LenSx laser system for procedures involving non-Alcon TORIC intraocular lenses. The defect is triggered if a user inadvertently activates a 'IOL 100% - RI 0%' slider within the software. Crucially, this added curve is not visible on the VERION system's graphical interface but becomes apparent only on the final exported or printed document. Utilizing a surgical plan with such an unintended curve could lead to an overcorrection of astigmatism, potentially reducing patient visual acuity.

To rectify this, Alcon requires specific user actions. Before finalizing any surgical plan for non-Alcon TORIC IOLs, users must click the 'IOL 100% RI 0%' slider arrow on the VERION system and verify that no arc appears on the exported or printed plan. If an arc is present, the plan must be re-processed by re-clicking the slider and re-exporting. Similarly, users of the Digital Marker L/LenSx Laser System must confirm the absence of an arc on their displayed surgical plan, returning to the VERION system for correction if necessary. Plans for Alcon intraocular lenses and non-Alcon non-TORIC intraocular lenses remain unaffected.

Company: https://www.globalkeysolutions.net/companies/alcon-gps-wavelight-gmbh/1f2ab517-d274-4f72-89e8-5541d07a1166/