CIBA Vision voluntarily recalls spherical contact lens

Duluth, GA-CIBA Vision Corp. is voluntarily recalling select lots of its spherical O₂Optix (lotrafilcon B) soft contact lenses in the United States and other countries. None of the company’s other lenses is involved in the recall.

“We identified that some lenses in these lots may fall below our standard for ion permeability, a material characteristic that correlates with lens movement on the eye,” said William D. Schaeffer, global head of quality for CIBA Vision, in the Jan. 12 recall notice. The FDA is aware of the action, according to the company.

The recalled lenses were distributed between September and December 2006.

“The potential medical safety risk to consumers posed by lenses with reduced ion permeability includes discomfort, foreign body irritation, and superficial localized corneal staining,” Schaeffer wrote. “The possibility of occurrence of these findings is moderate. As with any staining of the corneal tissue, the risk of corneal infection is somewhat increased, although the probability is remote.”

A separate company statement indicated that symptoms typically resolve within 2 to 24 hours of lens removal. The company has improved its manufacturing processes and has addressed the ion permeability issue, the statement said. Lens availability in the United States is expected to be affected into the second quarter of the year.

For more information, a list of affected lots, and instructions on returning lenses to the company, see www.us.cibavision.com/lenses/statement.shtml.