Health giant Johnson & Johnson (JNJ) has issued its ninth recall of a consumer health product in a year, this time covering millions of 1 Day Acuvue contact lenses sold in Japan and two dozen other countries in Asia and Europe.
The affected contact lenses were mostly sold in Japan and none were sold in the U.S. or Canada, the company said.
Johnson & Johnson said Monday it had received a limited number of complaints from customers in Japan that they experienced an unusual stinging or pain when inserting the Acuvue TruEye Brand contact lenses.
Long-Term Damage Unlikely
J&J, based in New Brunswick, N.J., said it has not received any reports of customers suffering damage to their vision.
"The risk of long-term health consequences is very unlikely," Gary Esterow, spokesman for Johnson & Johnson Vision Care Inc., told The Associated Press.
He said the company estimates about 100,000 boxes were affected, with the boxes containing either 30 or 90 lenses each.
"In most instances, people put (a lens) in one eye, realized it was uncomfortable and took it out," so only one eye was affected, Esterow said.
Problem's Already Fixed
The recall began in Japan when Johnson & Johnson notified the Japanese government on Aug. 18. The company did not announce the recall in the U.S.
Esterow attributed the problem to a failure of a piece of equipment during a procedure when the lenses are rinsed. One of the substances used in the manufacturing process was not entirely removed during the rinse.
He said only one manufacturing line was involved but would not say how many lines manufacture the contacts. The lenses are manufactured in Ireland.
The company has examined the manufacturing equipment, determined the cause of the problem and corrected it, Esterow said.
J&J said some of the affected lenses had not been shipped and were destroyed.
Customers in countries where the affected lenses were sold were being directed to check the lot number on the package, compare it with the affected lot numbers on J&J Web sites in each country, and return affected products to receive replacement lenses.
Johnson & Johnson has issued eight previous recalls of nonprescription medicines in the U.S. since last September, including children's Tylenol and millions of bottles of other pain relievers and cold medicines for children and adults.
As a result, Johnson & Johnson has been under scrutiny by Congress, Food and Drug Administration officials and federal prosecutors.
The series of recalls covered products made at J&J's Fort Washington, Pa., plant and another in Las Piedras, Puerto Rico. They have involved problems ranging from contamination with bacteria and a nauseating smell on containers to liquid medicines that may contain tiny metal shavings and drugs that may not have the correct amount of active ingredient.
Last week, Johnson & Johnson said it was creating a new position to oversee quality, manufacturing and compliance issues across the company and appointing chief quality officers for each of its three major divisions: prescription drugs, consumer health products and medical devices.