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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00312-1
Product Name/Description	KARMA Corneal Inlay Model Number: ACI 7000 ARTG Number: 222615
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/04/2015
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	Emergo Australia is informing users that the Laser-Over-Inlay product bulletin originally issued in November of 2013 (RC-2013-RN-01254-1) is being updated by the manufacturer (Acufocus). This update includes an additional precaution regarding use of lasers with the KAMRA Inlay in place. AcuFocus is recommending the removal of the inlay prior to any laser-based glaucoma therapy.
Recall Action	Recall for Product Correction
Recall Action Instructions	Emergo Australia is notifying the users of the updated instructions in the Laser-over-Inlay product bulletin.
Contact Information	02 9006 1662 - Emergo Australia