Johnson & Johnson Vision Care recently expanded its voluntary recall of 1-Day Acuvue TruEye disposable contact lenses.
The precautionary recall is due to residual traces of a chemical from the manufacturing process on some lenses that can cause stinging and redness upon lens insertion.
This expansion of the company’s voluntary recall of the product that began in August 2010 includes approximately 492,000 boxes of 1-Day Acuvue TruEye lenses sold outside the United States. Nearly 75 percent of the affected product is in Japan and countries within Europe and Asia Pacific, as well as Canada.
The product recall does not affect 1-Day Acuvue TruEye disposable contacts sold in the United States, which are made with a different lens material, according to the company.
In addition to the potential for some lenses to have higher than expected levels of a processing aid linked to consumer comfort complaints, the company’s review of its manufacturing process also found a small percentage of 1-Day Acuvue TruEye lenses in the affected lots do not meet the company’s quality standards.
Though the company’s complaint monitoring indicates no increase in health-related problems associated with wearing the affected lenses, Johnson & Johnson Vision Care is recalling the affected lenses as a precaution so consumers will experience the comfort they expect from 1-Day Acuvue TruEye lenses, according to an announcement posted on the company’s U.K. Acuvue website.
Regulatory authorities in all countries with affected lot numbers have been notified and the expanded voluntary recall affects less than one percent of all contact lenses made worldwide by Johnson & Johnson, the company says.
The U.K. Medicines Healthcare Products Regulatory Agency (MHRA) posted a notice of the recall on the agency’s website this week, but the company says it issued recall notices in various countries beginning in late October.
To identify 1-Day Acuvue TruEye lenses included in the recall, wearers are instructed to locate the multi-digit lot number that appears on the lens box and on the foil cover of individual lens containers. Lot numbers included in the recall begin with 492 or 502, with the first six digits falling between 492237 to 492498 and between 502080 to 502269.
Consumers are advised to discontinue use of 1-Day Acuvue TruEye disposable contacts meeting this description and contact their eye care professional for information on how to return product and obtain replacement lenses.