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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