The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Proclear Toric Soft Hydrophilic Contact Lenses manufactured by Coopervision.
The manufacturer's investigation of the complaints received have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
According to the manufacturer, there is no 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.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to the following link:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01039-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 03 October 2014