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Enforcement Actions

20/20 Institute, Indianapolis Lasik 12/18/12

  

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

 

WARNING LETTER
 
December 18, 2012
 
 
Mark S. Danzo, O.D.
Founder
20/20 Institute, Indianapolis Lasik
8500 Keystone Crossing Suite 150
Indianapolis, Indiana 46240
 
Dear Dr. Danzo:
 
The Food and Drug Administration (FDA) has learned that the 20/20 Institute, Indianapolis Lasik (“20/20 Indianapolis Lasik”) is promoting on its website (www.2020lasikindianapolis.com) the WaveLight Allegretto Wave Eye-Q Laser in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  This excimer laser is a device within the meaning of section 201(h) of the Act, 21 U.S.C. § 321(h), because it is 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 any function of the body.  As described below, 20/20 Indianapolis Lasik’s promotion of the WaveLight Allegretto Wave Eye-Q Laser misbrands the device under sections 502(a) and (q) of the Act, 21 U.S.C. §§ 352(a) and (q). 
 
Lasers such as the WaveLight Allegretto Wave Eye-Q Laser, which are used in refractive procedures such as laser-assisted in-situ keratomileusis (LASIK), are restricted devices pursuant to section 515(d)(1)(B)(ii) of the Act, 21 U.S.C. § 360e(d)(1)(B)(ii). Section 502(a) of the Act provides that a device is misbranded if its labeling is false or misleading in any particular. Section 502(q) of the Act provides that a restricted device is misbranded if its advertising is false or misleading in any particular. According to section 201(n) of the Act, 21 U.S.C. § 321(n), in determining whether a device’s labeling or advertising is misleading, the extent to which the labeling or advertising fails to reveal material facts, including the consequences that may result from the use of the device, must be taken into account.[1] It is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device, if such act is done while the device is held for sale after shipment in interstate commerce, and results in the device being adulterated or misbranded. [2]
 
20/20 Indianapolis Lasik’s website, “Custom Lasik,” available at http://www.2020lasikindianapolis.com/why-2020/advanced-fda-approved-technology/custom-lasik, states:
 
The Wavelight Allegretto Eye-Q Laser employs an innovative eye tracking capability for ultimate protection against eye movement and the most accurate corneal correction placement regardless of eye movements during your procedure. 
. . .
 
In addition to its extreme accuracy, the Wavelight Allegretto Eye-Q Laser also has fast treatment times.  It is currently the fastest FDA-approved LASIK laser, delivering results in about one-quarter of the time of other lasers.  The average prescription is treated in less than 10 seconds.
 
Moreover, the webpage entitled, “Lasik 101: Lasik Safety” states:
 
While LASIK is a relatively quick and seemingly easy procedure from the patients [sic] prospective [sic], like any other surgical procedure, it requires expertise on the part of the surgeon and it comes with both risks and benefits. While the risks are extremely small, there still is some risk. In general the risk of complication in LASIK is less than one half (½) of one percent (1%), however you should discuss your individual risks and benefits with your doctor.
 
20/20 Indianapolis Lasik website, “Lasik 101: LASIK Safety,” available at http://www.2020lasikindianapolis.com/lasik-101/lasik-safety. 
 
However, 20/20 Indianapolis Lasik’s website, including the statements above, fails to reveal material facts, including relevant risk information associated with the use of the WaveLight Allegretto Wave Eye-Q Laser.
 
It is critical to disclose risk information appropriately and effectively to consumers in all advertising and labeling concerning a restricted device such as the WaveLight Allegretto Wave Eye-Q Laser.  Risk information may include contraindications, warnings, precautions, and adverse events. FDA has available on its website background and risk information that may be helpful when developing advertisements and promotional materials concerning FDA-approved lasers used in LASIK procedures. See http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm. The approved labeling for each laser approved for LASIK, including the WaveLight Allegretto Wave Eye-Q Laser (P020050 and P030008), can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm192109.htm. In addition, information on the most common risks associated with refractive lasers intended for LASIK procedures is available at FDA’s LASIK website at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061354.htm. As noted on that website, common risks include the risks of dry eye syndrome, which can be severe; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision, which can be debilitating; and the loss of vision.  
 
FDA requests that 20/20 Indianapolis Lasik immediately cease promoting the WaveLight Allegretto Wave Eye-Q Laser in violation of the Act.  The 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 FDA without further notice. These actions may include, but are not limited to, seizure, injunction, and civil money penalties. 
 
Please notify this office in writing within fifteen business days from the date that you receive this letter of the specific steps that 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 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 sent to:
 
Toni Stifano
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3654
Silver Spring, MD 20993
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the firm’s violations. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.   
 
Sincerely yours,
/S/
Steven Silverman
Director
Office of Compliance
Center for Devices and
 Radiological Health


 
[1] On September 23, 2011, FDA issued a letter to eye care professionals regarding the promotion and advertising of FDA-approved lasers used during refractive procedures, including LASIK. See http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm272960.htm. In this letter, FDA emphasized the importance of providing adequate risk information in the advertising and promotion of FDA-approved lasers used in refractive procedures and directed eye care professionals to additional relevant information. As explained in the letter, lasers used in refractive procedures are restricted devices and are misbranded under the Act if their labeling or advertising is false or misleading.  FDA also issued letters to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology. See http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm297512.htm; http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm297514.htm.
 
[2] A clinic’s use of a device in patient treatment constitutes “holding for sale.”  See, e.g., United States v. Diapulse Corp. of Am., 514 F.2d 1097, 1098 (2d Cir. 1975).