Inspections, Compliance, Enforcement, and Criminal Investigations
Bausch & Lomb ELC SPL 6/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
JUN 11, 2012
VIA UNITED PARCEL SERVICE
Michael A. Santalucia
Vice President, Global Regulatory Affairs
Bausch & Lomb, Inc.
1400 North Goodman Street
Rochester, New York 14609
RE: PureVision 2 (balafilcon A) contact lenses, P980006
Refer to CPT1100062 when replying to this letter.
Dear Mr. Santalucia:
The Food and Drug Administration (FDA) has learned that your firm is marketing PureVision 2 contact lenses in the United States (U.S.) without appropriate premarket approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Act 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
The Office of Compliance, in FDA's Center for Devices and Radiological Health (CDRH), has reviewed your firm's website www.bausch.com, and other promotional materials for the Pure Vision 2 contact lenses. As described below, we have found that your firm is making claims for these devices that are misleading and that your firm is marketing the devices without required premarket approval.
Under P980006, FDA granted your company premarket approval for the PureVision 2 (balafilcon A) visibility tinted contact lens and PureVision 2 multi-focal (balafilcon A) visibility tinted contact lens with the following indications for use:
The Pure Vision 2 (balafilcon A) visibility tinted contact lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +8.00D to -20.00D when prescribed for up to 30 days of extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days.
The Pure Vision 2 multi-focal (balafilcon A) visibility tinted contact lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +6.00D to -18.00D when prescribed for up to 30 days of extended wear and from +20.00D to-20.00D for daily wear or extended wear up to 7 days with add powers ranging from +0.75D to +5.00D.
FDA received a supplement to P980006 from your firm on July 22, 2010, (P980006/S015) which requested approval for an alternate packaging solution of borate buffered saline with (b)(4) for the balafilcon A contact lens product family. Your firm also submitted revised labeling with device performance claims for Pure Vision 2 contact lenses in P980006/S015/Al that included representations that the lenses were "HD High Definition" and "ComfortMoist."
FDA sent your firm a letter on May 26, 2011, stating that P980006/S015 was not approvable. (b)(5)
Our recent review of your firm 's website and promotional materials, however, demonstrates that your firm is marketing Pure Vision 2 contact lenses with these claims without premarket approval. The objectionable claims include, but are not limited to, the following:
Our recent review of your firm’s website and promotional materials, however, demonstrates that your firm is marketing PureVision 2 contact lenses with these claims without premarket approval. The objectionable claims include, but are not limited to, the following:
• “Do you want crisp, clear vision, especially in low light? PureVision2 HD contact lenses are designed to reduce halos and glare while giving you the health and comfort you need.” 1
• “ComfortMoist Technology delivers outstanding comfort on insertion and supports wearing comfort throughout the day.” 2
These devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved PMA in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The kind of information that your firm needs to submit in order to obtain approval for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Additionally, your firm '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. Therefore, these devices are misbranded under sections 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is misleading in that the claims associated with the "HD High Definition" representation are not adequately substantiated by data.
The Office of Compliance requests that Bausch & Lomb, Inc. immediately cease marketing the PureVision 2 lenses with the representations described above. Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject device are corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm' s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to:
Ms. Toni Stifano
Food and Drug Administration
Center for Device and Radiological Health
10903 New Hampshire A venue
Silver Spring, MD 20993
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm 's responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations noted in this Jetter, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and
1 See http://www.bausch.com/en/Our-Products/Contact-Lenses/Contact-Lenses-for-Nearsighted-Farsighted/Purevision-2-HD-contact-lenses.
2 See http://www.purevison2.com/about.html.