CIBA VISION Corporate Statement

January 2007 Spherical O2OPTIX™ Recall & Supply

In January 2007, CIBA VISION conducted a voluntary trade-level recall from eye care professional, retailer and distributor inventories of select lots of spherical O2OPTIX™ (lotrafilcon B) contact lenses, distributed primarily in the United States, and to a lesser degree in other countries, excluding Japan. No other CIBA VISION lenses were involved with this recall. CIBA VISION notified the appropriate health authorities of this voluntary trade-level recall as well as our customers.

This recall was voluntary, proactive, and represented a responsible course of action to assure our products consistently meet customer expectations. We took this action after identifying that some lenses in these lots did not meet our standards for ion permeability, a material characteristic which contributes to lens movement on the eye.

A medical assessment, confirmed by external experts, determined that the probability of a serious adverse event associated with use of lenses with reduced ion permeability is remote. However, these lenses may cause persistent discomfort and/or foreign body irritation, and superficial corneal staining may be observed. The medical risk associated with these signs and symptoms is low to negligible, and upon removal of the lens, they typically resolve within 2-24 hours. No serious adverse events have been attributed to this issue anywhere in the world.

CIBA VISION already implemented manufacturing process improvements, and the ion permeability issue has been addressed. However, product availability will continue to be affected. We recognize the impact of this recall and product availability issues on our customers and consumers and we appreciate their patience and continued support. We have already taken significant measures to build more capacity and strengthen our manufacturing and quality infrastructure. We are confident that over time all of these combined changes will give us the capacity and flexibility to meet the expectations of our customers in the future.

For Eye Care Professionals
Click here for the eye care professional letter distributed in the United States regarding the O2OPTIX™ recall, with the knowledge of the FDA. The lot numbers in this letter apply strictly to the United States. Lot numbers in your country may vary. If you are outside of the United States, please check the CIBA Vision web site in your country, or speak with your local sales or customer service representative for specific lot numbers affected by this recall in your country.