Johnson & Johnson Vision Care has voluntarily recalled its 1•Day Acuvue TruEye contact lenses following complaints of eye irritation by contact lens wearers in Japan.
The voluntary recall has extended to Australia and New Zealand with a company spokesperson saying that the quantity of affected product in Australia and New Zealand was extremely limited.
“In cooperation with the TGA and Medsafe, we have initiated a voluntary retail-level recall and have been in contact with all 15 retailers who stocked the affected product,” the Australian spokesperson said.
The Company says it has contacted all 11 retailers in Australia and all four retailers in New Zealand who stocked the affected product.
We can confirm that this voluntary recall is only for select lots of 1•DAY ACUVUE TruEye Brand Contact Lenses (narafilcon A). No other products in the ACUVUE family are affected and 1•DAY ACUVUE TruEye contact lenses that have not been affected by the recall can continue to be used…
“In addition, we can confirm that this voluntary recall is only for select lots of 1•DAY ACUVUE TruEye Brand Contact Lenses (narafilcon A). No other products in the ACUVUE family are affected and 1•DAY ACUVUE TruEye contact lenses that have not been affected by the recall can continue to be used,” said the spokesperson.
“Most of the affected product is in Japan. Some countries within Asia and Europe may also have a limited number of affected product. In each of these countries, we are working in cooperation with regulatory authorities, eye care professionals and others who distribute our products to retrieve, destroy, and replace all 1•DAY ACUVUE TruEye product that may be affected by this voluntary recall”.
The company issued a statement from its U.S headquarters stating: “Johnson & Johnson is voluntarily recalling select lots of 1•Day Acuvue TruEye Brand Contact Lenses (narafilcon A) manufactured in Ireland and distributed in Japan, as well as several countries within Asia and Europe. No other markets, including the United States (which markets a different version of 1•Day Acuvue TruEye made with narafilcon B), are affected.
“Johnson & Johnson Vision Care is initiating this voluntary recall because it received a limited number of customer complaints in Japan associated with these affected lots of narafilcon A contact lenses. Some of the reported complaints described an unusual stinging or pain upon inserting with narafilcon A contact lenses. Most events involved one eye of the patient. Long term health consequences arising from this situation would be unlikely.
“Upon investigation, the company determined an isolated issue in one portion of the lens rinsing process on a particular manufacturing line in a select number of lots. The investigation has determined that no other lots of this product nor any other Acuvue product have been associated with this manufacturing issue. All 1•Day Acuvue TruEye contact lenses without the affected lot numbers can continue to be used.
“In addition to the voluntary recall of affected products released to the market, the company has suspended shipment of the affected lots still in its control and, following a comprehensive quality assessment has implemented corrective actions to ensure that products meet the company’s carefully controlled standards.”
The statement concluded, “Johnson & Johnson Vision Care affiliates in Japan, Asia, and Europe are working in cooperation with regulatory authorities, eye care professionals and others who distribute our products to retrieve, destroy, and replace all 1•Day Acuvue TruEye (narafilcon A) product that may be affected by this voluntary recall. The company is also providing replacement contact lenses to customers who have any of the products with the affected lot numbers.”
