CIBA VISION Corporate Statement

O2OPTIX™ Recall & Supply

CIBA VISION Corporation is conducting a company-initiated, retail-level only, recall on select lots of spherical O2OPTIX (lotrafilcon B) soft contact lenses in Australia, New Zealand and other countries. No other CIBA Vision lenses are involved in this recall.  
“CIBA VISION is taking this voluntary action to assure our products consistently meet customer expectations. We identified that some lenses in these lots may fall below our standard for ion permeability, a material characteristic that correlates with lens movement on the eye”, says Dan Hammond, Managing Director CIBA VISION, Australia and New Zealand. 

A medical assessment, confirmed by external experts, determined that the probability of a serious adverse event associated with use of these lenses 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 related to this issue have been reported anywhere in the world. A recall from patients is not required.

CIBA VISION has already implemented manufacturing process improvements, and the ion permeability issue has been addressed. However, product availability will continue to be affected in Australia and New Zealand.  Supply constraints are expected throughout Q1/2007 with increasing improvements through mid-year.

“We recognize the impact of this recall and product availability issues on our customers and their patients 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”, states Dan Hammond.   

For further questions please contact CIBA VISION Customer Service in Australia on 1800 224 153 or New Zealand on 0800 93 8888.