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Re: O2 Optix Recall
| Mike Tyner | 17 Jan 2007 14:39 |
>I got a blast from the OEBB list stating that a recall on CIBAVision's > O2 Optix was imminent. Anyone got the scoop? CIBA Vision CORPORATE STATEMENT
O2OPTIXT Recall & Supply
CIBA Vision is conducting a voluntary trade-level recall of select lots of spherical O2OPTIXT (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 are involved with this recall. CIBA Vision has notified the appropriate health authorities of this voluntary trade-level recall and is currently notifying customers.
This recall is voluntary, proactive, and represents a responsible course of action to assure our products consistently meet customer expectations.
We are taking this action because we have identified 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 has 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.
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| Anon E. Muss | 17 Jan 2007 04:57 |
I got a blast from the OEBB list stating that a recall on CIBAVision's O2 Optix was imminent. Anyone got the scoop?
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