Tuesday, January 23, 2007
O2Optix Contact Lens Recalled
CIBA VISION CONDUCTS VOLUNTARY TRADE-LEVEL RECALL OF O2OPTIX CONTACT LENSES. CIBA Vision is conducting a voluntary trade-level (not consumer) recall 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). The company says it is taking this action after identifying some lenses in the recall lots that did not meet the proper standards for ion permeability, a material characteristic contributing to lens movement on the eye. No other CIBA Vision lens brands are involved in the recall. The company has notified the appropriate health authorities of the recall and is currently notifying customers. A medical assessment, confirmed by experts outside the company, determined that the probability of a serious adverse event associated with use of lenses with reduced ion permeability is remote; however, the 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 lens removal they typically resolve within two to 24 hours. CIBA Vision stresses that no serious adverse events have been attributed to the issue. Although it has begun improving its manufacturing process for the O2Optix lens and has addressed the ion permeability issue, product availability will continue to be affected. In the United States, the company anticipates significant supply constraints and backorders of the lens into the second quarter, with increasing improvements through mid-year.