Contact Solution Recall Blog

In a press release disseminated in January, AMO Inc., the manufacturer of Complete Moisture Plus contact lens solution, announced that it would delay the launch of its Tecnis(R) Multifocal intraocular lens (IOL) by 12 to 18 months from the originally-scheduled date of release, which was set for the first half of 2008.

The reason for the delay is because the FDA requested that AMO, Inc. perform additional tests on the product before releasing it into the market.  Specifically, the FDA would like the company to test a higher number of subjects than have already been tested. 

AMO, Inc. has already been embroiled in much controversy with another one of its products, Complete Moisture Plus contact lens solution, but according to their press release, the company does not see an issue with this delay. 

“Rather, the possible delay is related to sample size assumptions from the protocol established in the investigational device exemption (IDE) application that was approved by the FDA before our

U.S. trial commenced in late 2004. We respect the FDA’s views and intend to continue a dialogue with them in an effort to satisfy their questions,” according to Dr. Leonard Borrmann, AMO corporate vice president, research and development.

If you have been injured as a result of using any AMO Inc. product, including Complete Moisture Plus contact lens solution, schedule a free initial consultation with the contact lens recall lawyers at Williams Kherkher today.