Quality improvements at Johnson & Johnson was the focus of last week’s news about the company. This week, unfortunately, it’s back to recalls and warning letters.
J&J issued a recall of millions of its daily disposable contact lenses, 1 Day Acuvue, sold in Japan and more than two dozen other Asian and European countries, according to a report from the Associated Press. Consumers complained that they experienced a stinging sensation when inserting the lenses. The company estimates that the recall includes roughly 100,000 boxes of contact lenses. The recalled lenses were not sold in the US or Canada, and J&J did not announce the recall in the US.
According to a company spokesperson interviewed by AP, the problem arose because a piece of equipment failed during manufacture and the lenses were not properly rinsed, and the recalled lenses contain a substance that was used in the manufacturing process. The company has identified and corrected the problem, which affected only one manufacturing line in the Ireland-based manufacturing facility, according to the AP report.
In related J&J news, this week the US Food and Drug Administration posted on its website an Aug. 19 Warning Letter to DePuy Orthopaedics, a business unit of J&J that makes joint replacements, issued for marketing violations for two of its products. FDA says it never approved the sale of DePuy’s TruMatch Personalized Solution System, a device that features proprietary software and a CT scanner that produces a three-dimensional model of a patient’s knee prior to knee replacement surgery. FDA’s letter also states that DePuy marketed its Corail Hip System for two uses that were not approved by the agency. The agency asked DePuy to stop marketing the products and correct the violations detailed in the letter.