September 22, 2008
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Court orders Ocular Insight to discontinue claims for Clear 58 contact lenses

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JACKSONVILLE, Fla. — A New York district court has ordered Ocular Insight to permanently halt a number of advertising and promotional claims in the United States concerning the company's Clear 58 contact lenses and their likeness to Johnson & Johnson's Acuvue 2 brand contact lenses, Johnson & Johnson announced in a press release.

Specifically, the court order forbids Ocular Insight from claiming that its Clear 58 lens has been approved by the U.S. Food and Drug Administration and that the lens has been approved as a generic equivalent to the Acuvue 2 brand lens. In addition, Ocular Insight is prohibited from claiming that its Clear 58 lens is a generic equivalent or exact duplicate of the Acuvue 2 lens, according to the release.

"In the interest of patient safety, we felt an urgent need to address these misleading claims as quickly as possible," Naomi Kelman, president of the Americas region for Vistakon, a division of Johnson & Johnson, said. "While Clear 58 has been 'cleared' for marketing by the FDA, it has not been 'approved' by the agency. Furthermore, the FDA does not perform the function of assessing whether a contact lens may be prescribed as a 'generic equivalent' lens."