JACKSONVILLE, Fla., Sept. 18 /PRNewswire/ -- Following a complaint filed in July 2008 by Johnson & Johnson Vision Care, Inc., a United States district court in New York has ordered, on both parties' consent, Ocular Insight, Inc. to permanently discontinue stating or communicating in its advertising or promotional materials or activities to eye care professionals for the company's Clear 58(R) contact lenses in the United States, any of the following claims:
"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(R), 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(R) 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(R) 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(R) 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. "Contact lenses are medical devices that require a prescription, and contact lens wearers should never substitute a different brand than they presently have without the approval of their eye doctor."
ACUVUE(R) and VISTAKON(R) are trademarks of Johnson & Johnson Vision Care, Inc.
CONTACT: Gary Esterow of Vistakon, +1-908-216-5200, gester1@its.jnj.com
Web site: http://www.jnjvision.com/
