Following complaint by Johnson & Johnson Vision Care, Inc., court orders Ocular Insight, Inc. to discontinue certain advertising/promotional claims about its Clear 58® contact lenses
JACKSONVILLE, Fla (September 16, 2008) – Following a complaint filed in July 2008 by Johnson & Johnson Vision Care, Inc., a United States district court in New York has ordered Ocular Insight, Inc. to permanently discontinue stating or communicating in its advertising or promotional materials or activities for the company’s Clear 58® contact lenses in the United States, any of the following claims:
• that Clear 58 is approved by the Food & Drug Administration (FDA);
• that Clear 58 is approved by the FDA as a generic equivalent lens to ACUVUE® 2 Brand Contact Lenses;
• that Clear 58 is a generic equivalent to ACUVUE® 2; and
• that Clear 58 is an exact duplicate or is identical to ACUVUE® 2.
“In the interest of patient safety, we felt an urgent need to address these misleading claims as quickly as possible,” says Naomi Kelman, President, Americas, VISTAKON®, Division of Johnson & Johnson Vision Care, Inc. “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.”
And, according to Ms. Kelman, testing of the Clear 58 lens by Johnson & Johnson Vision Care shows that it is different from ACUVUE® 2 in material respects that would be expected to affect visual acuity, handling and/or comfort.
“Contact lens design and the manufacturing process are two key factors that differentiate contact lenses, explains Ms. Kelman. “The proprietary lens design and manufacturing process of all ACUVUE® Brand Contact Lenses are unique. In many cases, these differences in design and manufacture distinguish them from other contact lenses in areas such as comfort, eye health and vision. The Clear 58 product does not share the same characteristics that have long provided comfort and vision benefits to ACUVUE® 2 wearers and therefore may perform optically and physically differently on the eye.
“Doctors write prescriptions for the particular contact lens brand that best fits the overall comfort, eye health, and vision needs of the patient,” she adds. “Eye care professionals who relied on Ocular Insight’s now banned claims may not have been able to make appropriate prescribing decisions. As a result, they may have prescribed Clear 58 lenses to patients for whom the ACUVUE® lenses may be more comfortable and efficacious.”
ACUVUE® and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.
