Inspections, Compliance, Enforcement, and Criminal Investigations
Hoya Surgical Optics, Inc. 8/2/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
AUG 2, 2011
VIA UNITED PARCEL SERVICE
Mr. Thomas Dunlap
Global President and CEO
Hoya Surgical Optics
14768 Pipeline Avenue
Chino Hills, California 91709
Dear Mr. Dunlap:
The Food and Drug Administration (FDA) has learned that your firm is marketing intraocular lenses, iSymm models FC-60AD and PC-60AD in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (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 are intended to affect the structure or function of the body.
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your web site, www.hoyasurgopt.com and a letter submitted to the FDA dated January 14, 2011. These devices are intended to be used for visual correction of aphakia following cataract surgery. According to your letter dated January 14, 2011, during the time period of August 1, 2009 to July 31, 2010, you shipped (b)(4) lenses of model FC-60AD and (b)(4) lenses of model PC-60AD. You sold (b)(4) lenses of model FC-60AD and (b)(4) lenses of model PC-60AD. Our records indicate that these intraocular lens models have never been approved for sale in the United States.
The iSymm models FC-60AD and PC-60AD are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within 15 business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this WL.
Your response should be sent to: Field Operations Branch/DRMO/OC at the Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 2613, Silver Spring, Maryland, 20993. If you have any questions about the content of this letter please contact: Debra Demeritt at 301-796-5770 or fax 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and