Inspections, Compliance, Enforcement, and Criminal Investigations

D.O.R.C. Intl. B.V. 9/1/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

SEP 1, 2015

WARNING LETTER
VIA United Parcel Service
 
Theo Sonnenberg
CEO
D.O.R.C. (Dutch Ophthalmic Research Center) International B.V.
Scheijdelveweg 2
Zuidland, Netherlands
 
Dear Mr. Sonnenberg:
 
During an inspection of your firm located in Zuidland, Netherlands on September 8, 2014 through September 12, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Associate 6000 phaco-fragmentation systems.  
 
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 to affect the structure or function of the body.
 
Our inspection revealed that the Associate 6000 phaco-fragmentation system (previously identified as the Associate 2500) is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), in that it is a class III device under 513(f) of the Act, 21 U.S.C. 360c(f) and does 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). The Associate 6000 phaco-fragmentation system is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 C.F.R. 807.81(a)(3)(i).
 
Specifically, you have modified the Associate 2500 Dual and Compact Systems, cleared under K081877, by changing the cutting speed from 100 - 2500 to 20 - 6000 cycles per minute, the lighting from halogen bulb to LED based illumination, increasing the deliverable aspiration vacuum level, and making multiple software revisions from GUI3.00/EPB4.00 to GU15.00/EPB6.00. The device modifications require a new 510(k) since the changes could significantly affect the safety or effectiveness of the device. For example, the increases in cutting speed could result in unintended tissue heating, and increases in the vacuum aspiration level could result in excessive negative pressure, posing a risk of tissue damage.
 
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 C.F.R. 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/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 
Given the serious nature of the violations of the Act, Associate 6000 phaco-fragmentation systemsare subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. 
 
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 (which must address systemic problems) 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:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number “CMS 453349”when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Debra E. Demeritt, Chief of Surveillance and Enforcement Branch II Division of Premarket and Labeling Compliance, Office of Compliance, Center for Devices and Radiological Health 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 firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA. 
 
 
Sincerely yours,
/S/ 
Jan B. Welch, MHS, MT (ASCP) SBB
Acting Director,
Office of Compliance
Center for Devices and
    Radiological Health

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