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TGA Action ID	RC-2026-RN-00630-1
Type of Product	Medical Device
Product Name/Description	Stella 2.0 Implant Orientation Diagram (IOD) Incorrect Axis Model Number: VTICMO Serial Number: T2690983 Date IOD Generated: 05/06/2026
ARTG Number	224233
Unique Device Identifier (UDI)	(01)00840311327430(11)260306 (17)290228(21)T2690983
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	STAAR Surgical has become aware that a limited number of IODs generated have the risk of an IOD with an incorrect axis value that could be clinically significant. Specifically, per the review of data in Stella 2.0, the IOD generated for a device previously ordered has a different axis placement than what had been reserved in Stella 2.0. If a Toric EVO/EVO+ device was implanted using an incorrect axis value, there is the potential for refractive surprise, blurred vision, glares/halos, and other visual disturbances. Removal or repositioning of the lens may need to be considered in these cases.
Instructions for Customers/Users	Customers are to refer to the enclosed annex for the correct IOD.
Action Commencement Date	18/08/2026
Responsible Entity	Device Technologies Australia Pty Ltd
Contact Information	1300 338 423 - Device Technologies