OFFICIAL-SOURCE RECALL · AUSTRALIA
Stella 2.0 Implant Orientation Diagram (IOD) Incorrect Axis Recall: Classification Class II Reason for the
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- Brand
- See official notice
- Product
- Stella 2.0 Implant Orientation Diagram (IOD) Incorrect Axis
- Manufacturer
- See official notice
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- numbers
- Batch number
- numbers
- Model number
- VTICMO
- Serial number / range
- T2690983
- Date code
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- Expiration date
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The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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
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
Official recall notice
Stella 2.0 Implant Orientation Diagram (IOD) Incorrect Axis
Agency: Therapeutic Goods Administration
Official publication date: June 5, 2026
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