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Re: O2 Optix Recall

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Re: O2 Optix Recall

Mike Tyner17 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.

Anon E. Muss17 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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