Acuvue TruEye - Contact Lenses - Recall by manufacturer

By **jpwise**. 24/08/10, 03:48 am

Not sure if this affects anyone in NZ since it looks like they were mostly sold overseas, but if anyone imported some and has had problems with stinging/etc this may be why.

http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10668468

Quote :: US health giant Johnson & Johnson is advising people to stop using its Acuvue TruEye Brand contact lenses following complaints from customers overseas that they experienced an unusual stinging or pain using them.

The company's US offices said the affected contact lenses were mostly sold in Japan. Its New Zealand help line recommended people discontinue using Acuvue TruEye Brand contact lenses and contact their optometrist.

The company itself could not be contacted.

Johnson & Johnson 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.

J&J, based in New Brunswick, New Jersey, 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.

The recall began in Japan when Johnson & Johnson notified the Japanese government on Aug. 18.

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 websites in each country, and return affected products to receive replacement lenses.

However, there were no details of the problem on the company's New Zealand websites this morning.

Johnson & Johnson has issued eight previous recalls of nonprescription medicines in the US 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, Pennsylvania, 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.

J&J shares rose 17 cents to $58.91 ($83.18) in late-afternoon trading Monday.

- AP