CIBA Vision AIR OPTIX Contact lens recall
Today we were made aware from CIBA vision Uk
Ltd that some of their contact lenses supplied to opticians in the UK and EU
have fallen below their accepted quality standards. They have voluntary
decided to recall the lenses affected.
The problem relates only to some batches AIR
OPTIX (O2 OPTIX) lenses.
No other CIBA or CIBA FOCUS products are
affected.
We have contacted all of our patients who
have received lenses from the batches affected.
Lenses from affected batches will be replaced
free of charge and although the risk to ocular health is remote we will
offer our patients affected an additional free contact lens examination for
their own peace of mind.
If you are one of our patients who wear AIR
OPTIX lenses and we have not contacted you, your lenses are from batches,
which are not affected by this recall. Please carry on with your contact
lens wear as normal.
CIBA Vision CORPORATE
STATEMENT TOPIC: AIR OPTIX®
Recall CIBA Vision is
conducting a voluntary trade-level recall of select lots of spherical AIR
OPTIX® contact lenses.
No other CIBA Vision lenses are involved with
this recall. CIBA Vision has notified the appropriate health authorities of
this voluntary trade-level recall. All affected practices will receive a
letter this week detailing the affected orders and batches shipped to their
practice.
This recall is voluntary, proactive, and
represents a responsible course of action to ensure 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. 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
recognise 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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