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TGA Action ID	RC-2025-RN-00927-1
Type of Product	Medical Device
Product Name/Description	TPSG2 RoboMarker G2 Tip Product Code: 61739 Lot Number 1006-C-5
ARTG Number	260688
Unique Device Identifier (UDI)	Not yet available
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	IQ Medical has become aware of a lot-specific problem concerning the TPSG2 RoboMarker G2 Tip. When used as per the instructions for use, excess ink may be deposited on the cornea, which may cause blurred lines and temporary corneal staining. The imprecise line markings may make it more difficult to achieve accurate Toric IOL alignment with the axis of astigmatism of the patient’s cornea, which may result in imprecise or failure of correction of the patient’s astigmatism. Additionally, corneal staining may trigger severe irritation to the cornea, which could potentially lead to corneal inflammation. This action has been undertaken prior to notification to the TGA.
Instructions for Customers/Users	Customers are to: - Immediately quarantine affected stock on hand to prevent further use - Return affected stock on hand with the completed response form to IQ Medical. IQ Medical will provide replacement stock. This action has been finalised on 10/2/2026.
Action Commencement Date	7/11/2025
Responsible Entity	IQ Medical
Contact Information	08 6275 7820 - IQ Medical Customer Service