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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00255-1
Product Name/Description VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning system for ophthalmic surgery)

Catalogue Number: 8065998240

ARTG Number: 214732
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/03/2016
Responsible Entity Alcon Laboratories Australia Pty Ltd
Reason/Issue Alcon has received reports concerning the inclusion of unplanned arcuate incisions on printed, saved (.pdf) or exported surgical plans. This situation only occurs when the VERION Reference Unit (Vision Planner) is used to create a surgical plan for non-Alcon toric Intraocular lenses (IOLs) that is used with the Alcon Verion Digital Marker LenSx Laser system. Surgical plans for Alcon toric IOLs as well as all spherical IOL regardless of brand are not affected.

These unintentional surgical plan arcuates can occur if the deactivated ‘IOL 100% – RI 0%’ slider bar is unintentionally activated by the user in the planning software. This directs the software to include the addition of arcuates for the surgical procedure and can only be seen on the exported, saved (.pdf) or printed surgical plans.
If the additional arcuates are performed this may lead to an astigmatism overcorrection resulting in reduced unaided visual acuity.
Recall Action Recall for Product Correction
Recall Action Instructions Alcon is providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent fix.
Contact Information 1800 224 153 (Option 3) - Alcon Technical Services