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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Woolfson Eye Institute 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
 
Jonathan Woolfson, M.D.
Founder and Medical Director
Woolfson Eye Institute
Perimeter Place
800 Mount Vernon Highway
Suite 130
Atlanta, Georgia 30328
 
Dear Dr. Woolfson:
 
The Food and Drug Administration (FDA) has learned that the Woolfson Eye Institute is promoting on its website (www.woolfsoneye.com) the WaveLight Allegretto Wave Eye-Q Laser and the VISX Star S4 Laser in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  These excimer lasers are devices within the meaning of section 201(h) of the Act, 21 U.S.C. § 321(h), 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 any function of the body.  As described below, Woolfson Eye Institute’s promotion of the WaveLight Allegretto Wave Eye-Q Laser and the VISX Star S4 Laser misbrands the devices 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 and the VISX Star S4 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]
 
Woolfson Eye Institute’s website, “Technology – Alcon Allegretto Wave (400 Hz),” available at http://www.woolfsoneye.com/lasik-technology-alcon-allegretto-wave.html, states:
 
Using the Wavelight Allegretto Wave® your Woolfson surgeon is able to apply tiny laser pulses to the cornea to sculpt its surface with the utmost accuracy.  The high-speed eye-tracker checks eye positions 4000 times per second to follow the eye’s fastest movements and ensure accurate placement of each laser pulse.  The Smart Energy Control feature further gives peace of mind that the amount of energy in the laser has been calibrated to exactly the right level.
            . . .
 
The Wavelight Allegretto Wave is also one of the fastest vision correction lasers for LASIK available in the United States.  The actual laser application only takes 2-15 seconds, depending on the correction necessary.  This speed translates to an easier and less stressful experience during your LASIK procedure.
 
The website also states:
 
The VISX Star S4 Laser System offers variable spot beam technology meaning that it adjusts the laser beam size according to the individualized treatment plan, minimizing corneal tissue removal.  This also allows for quicker treatment times that are typically between 10 to 40 seconds.
 
Woolfson Eye Institute website, “Technology – Abbot VISX Star S4 IR,” available at http://www.woolfsoneye.com/lasik-technology-abbott-visx.html.  
 
Moreover, the webpage entitled, “Glossary/FAQ.  Q.  Are there any Risks?” states: 
 
A. Yes, but less than 1% of LASIK patients develop complications that can reduce the quality of their corrected vision.  Our surgeons, staff doctors and your private eye doctor minimize the risk of problems by carefully evaluating your overall eye health and candidacy for LASIK.  The appropriate risks, benefits and expectations specific to your case will be addressed at your pre-operative exam and again before you go into surgery.
 
Woolfson Eye Institute, “LASIK Glossary FAQ,” available at http://www.woolfsoneye.com/lasik-faq.html.
 
However, Woolfson Eye Institute’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 and the VISX Star S4 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 and VISX Star S4 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) and the VISX Star S4 Laser (P930016) 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 Woolfson Eye Institute immediately cease promoting the WaveLight Allegretto Wave Eye-Q Laser and the VISX Star S4 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).