A warning letter sent to Rochester, NY-based medical device manufacturer Bausch & Lomb, Inc by the US Food and Drug Administration (FDA) accuses the company of marketing its PureVision 2 contact lenses using an explicitly unapproved indication.
In its 11 June 2012 letter, FDA explains Bausch submitted a supplement for the device-a tinted contact lens with an approved indication for extended wear-to the agency in 2010 seeking approval for a revised labeling statement indicating the devices were "HD High Definition" and "ComfortMoist."
FDA denied Bausch's application, and issued it a letter in May 2011 stating the supplement was "not approvable."
FDA said it found the company had continued to market the device using the unapproved claims in defiance of the agency's order. An FDA review of Bausch's website found the firm specifically continued to use the unapprovable claims "without premarket approval."
Marketing Based on an Unapproved Indication
Two statements posted to Bausch's website in October and November 2011 show the company started marketing the devices using the claims before hearing back from FDA.
An 18 November 2011 statement by Bausch indicated they had started wide-scale marketing of the device just four months after submitting its PMA supplement (P980006/S015) to FDA. "Bausch + Lomb announces the launch of PureVision®2 with High Definition™ Optics contact lenses, the latest development in the company's portfolio of lenses," the company wrote in a press release at the time.
"Designed to reduce glare and halos while delivering excellent vision, these new monthly contact lenses bring together several improvements to help overcome the challenges that contact lens wearers face, including spherical aberration, an optical effect that can result in blurred vision, glare and halos."
An earlier release-dated 12 October 2011-indicates the company started to market the device at the Annual meeting of the American Academy of Optometry (AAO) based on the "High Definition" label not yet approved by FDA. "PureVision2 HD For Astigmatism lenses reduce spherical aberration across both the cylinder and sphere meridians, as well as across the entire power range, thus helping to reduce halos and glare in low-light conditions," the company explained in the statement.
"Many astigmatic contact lens wearers report blurry, hazy and fluctuating vision. For people experiencing these symptoms, PureVision2 HD For Astigmatism contact lenses with High Definition Optics and Auto-Align Design™ may be an option that will help reduce these symptoms," said a company spokesman in the release.
On the same day FDA replied to Bausch with its rejection of its PMA supplement, the company released the results of a study it conducted on how "glare and halos are significant problems for people wearing glasses or contact lenses."
"Some spectacle designs as well as aspheric contact lenses may help patients achieve optimal visual correction with no halos or glare," wrote Carla Mack, Director of Bausch's Global Medical Affairs division. The company's PureVision 2 product is characterized by an "enhanced aspheric optical design," making it likely the press release was at least in part related to the product and perhaps indicating the company was expecting to receive a positive response from FDA.
'FDA Specifically Objected' to Marketing Claims
FDA's warning letter takes sharp aim at Bausch for marketing its products using the "HD" and "ComfortMoist" labels.
"[B&L's] promotional materials show the ;HD High Definition' representation on the carton labeling of the PureVision 2 contact lenses even though FDA specifically objected to the inclusion of this representation in the labeling due to insufficient performance data during the course of review of the PMA supplement for these lenses," wrote FDA in its letter.
FDA referred to the device as "misbranded" and called for the company to immediately cease the marketing of the device. As of 11 July, the company had altered its marketing materials for the device to reflect FDA's concerns.
Bausch Makes a "Good Faith" Response
In a statement to Regulatory Focus, Bausch's Vice President of Public Relations Jane Mazur saidBausch had "acted in good faith in making the marketing claims at issue with PureVision2® and PureVision2® For Astigmatism for daily wear use."
"However, we respect the FDA's position and we are actively working to resolve its concerns," wrote Mazur, who added the company is working with its suppliers and customers to update their websites. Several of those websites, including VisionDirect, 1-800-Contacts, and Contact Lens King still feature the product along with its unapproved "HD" designation.
Mazur said the company had worked to take down all copies of the incorrect marketing on its website, and the website no longer features the content, though the October and November 2011 press releases remained on the website. In addition, the current URL for the device still contains the string, "Purevision-2-HD-contact-lenses."
"Bausch + Lomb takes this matter very seriously and is working to address FDA's concerns and to ensure that we meet all FDA expectations," concluded Mazur. "Pursuant to the agency's request, we are not marketing PureVision®2 and PureVision®2 For Astigmatism for extended wear."