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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01039-1
Product Name/Description	Proclear Toric Soft Hydrophilic Contact Lenses Multiple lot numbers manufactured in 2012 ARTG number: 169193
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	1/10/2014
Responsible Entity	Coopervision Australia Pty Ltd
Reason/Issue	Coopervision's investigation of complaints have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. There is not likely to be added medical risk to an incorrect axis lens use, since the patient will notice the blur and visual disturbance right away and report it to the practitioner. Replacement of the lens with the proper power parameter in sphere and cylinder, and/or axis of astigmatism will alleviate the visual blur and disturbance.
Recall Action	Recall
Recall Action Instructions	Retailers (practitioners) are advised to stop any further patient order fulfilment of the affected lots of Proclear Toric lenses and quarantine them for returning it to Coopervision. Patients will be provided full refund for any affected product returned by them. This action has been closed-out on 17/05/2017.
Contact Information	1800 655 480 - Coopervision Customer Service