In its ninth recall this year alone, Johnson & Johnson is recalling millions of its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">1 Day Acuvue Contact Lenses, which were sold in Japan and two dozen other countries in Asia and Europe, the Associated Press (AP) reports.
None of the recalled contact lenses were sold in the U.S.; however, according to Medical News Today, the recall has been extended to include Australia, Germany, France, Russia, the United Kingdom, and Singapore. The recall initiated in Japan when the pharmaceutical giant advised the Japanese government on August 18th, wrote the AP, which added that Johnson & Johnson did not announce the recall in the U.S.
Johnson & Johnson announced it received complaints from its customers in Japan who complained of stinging or pain when inserting the Acuvue TruEye Brand Contact Lenses in their eyes, said the AP, which noted that no reports of vision damage have been received. “The risk of long-term health consequences is very unlikely,” Gary Esterow, spokesman for Johnson & Johnson Vision Care Inc., told the AP.
Esterow said the firm believes about 100,000 boxes of the 1 Day Acuvue TruEye Brand Contact Lenses are involved; each box contains 30 or 90 lenses, noted the AP. “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 added, quoted the AP.
Esterow said he believed the issue related to equipment failure that occurred when lenses are rinsed during production. It seems a substance used during manufacturing was not removed during the rinse process, explained the AP. Although only one manufacturing line was involved, according to Esterow, he did not indicate the number of lines are involved in manufacture of the recalled lenses, which were made in Ireland.
Esterow confirmed that Johnson & Johnson looked at its equipment and located and corrected the issue, said the AP; the firm said some lenses were never shipped and have been destroyed. Johnson & Johnson described the incident as “an isolated issue in one portion of the lens rinsing process on a particular manufacturing line affecting a limited number of lots,” quoted Medical News Today.
We recently wrote that Johnson & Johnson is expecting more legal fallout from its recent recalls of childrenâ€™s Tylenol and other over-the-counter medicines. According to a prior Wall Street Journal report, Johnson & Johnson said in a recent regulatory filing it received â€œcivil investigative demandsâ€ from various state authorities in connection with the recalls.
Johnson & Johnson has been under scrutiny since April 30, when its McNeil Consumer Healthcare unit recalled more than 40 varieties of <"http://www.yourlawyer.com/topics/overview/Childrens-Tylenol">childrenâ€™s Tylenol and other medicines. That recall was just one of six McNeil issued for its cold and pain relief products over the past year.
The New Jersey-based company has been hit with a federal subpoena from the U.S. Attorneyâ€™s Office for the Eastern District of Pennsylvania. The Journal also wrote that Congress is investigating the recalls, which have spawned numerous lawsuits. In a filing with the Securities and Exchange Commission (SEC), Johnson & Johnson disclosed it received multiple subpoenas from federal prosecutors requesting documents â€œbroadly relating toâ€ both the recent recalls and inspections of two factories and said it received demands from multiple State Attorneys General Offices relating to the same issues.