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CIBA Vision Recalls O2Optix
In a letter to eye care professionals dated Jan. 12, CIBA Vision Corp. issued a voluntary recall of selected lots
of O2Optix (lotrafilcon B) soft contact lenses after
the company found some lenses in those lots may fall below the standard for ion permeability, a material characteristic that is correlated with lens movement on
the eye. The effected lenses were distributed between Sept. 2006 and Dec. 2006 and include all lot numbers starting with 6644001 through 6721626 with expiration
dates starting from 2011/09 through 2011/11, as well as lot numbers 6626127, 6636101, 6637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119 and 6643080, all
with the expiration date of 2011/08.
The company says a medical assessment determined that the probability of a serious adverse event associated with these lenses is remote. However, they may cause
persistent discomfort, foreign body irritation and superficial corneal staining, usually within the first one to four hours of wear. As with any staining, the risk
of corneal infection is somewhat increased, although the probability is remote. Signs and symptoms generally resolve quickly upon removal of the lens.
CIBA Vision notes that no serious adverse events related to this issue have been reported globally. Only seven, non-serious complains that are likely related to the
use of O2Optix lenses with reduced ion permeability have been reported
to the company. Effected lenses should be sent back to the company along with the “Recall tracking form.” If you have not received this form, contact CIBA Vision Customer
Service at 1-800-241-5999.
The company says it has already implemented manufacturing process improvements and addressed the ion permeability issue. However, product availability will continue to be
effected. In the U.S., significant supply constraints and backorders into the second quarter are expected, with increasing improvements through mid-year.
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