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Johnson & Johnson Recalls 1•Day Acuvue Lenses in Japan, Asia and Europe

August 23, 2010 12:27 AM


MANALAPAN, N.J.—Responding to complaints of eye irritation by contact lens wearers in Japan and parts of Asia and Europe, Johnson & Johnson Vision Care initiated a voluntary recall on Friday of its 1•Day Acuvue TruEye contact lenses.

In a statement issued Friday, the contact lens maker said it 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.”

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