Inspections, Compliance, Enforcement, and Criminal Investigations

Pacific Vision Institute 8/14/14

  

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
AUG 14, 2014
Via United Parcel Service
 
Ella Faktorovich, M.D.
Founder
Pacific Vision Institute
One Daniel Burnham Court
San Francisco, California 94109
 
Dear Dr. Faktorovich:
 
The United States Food and Drug Administration (FDA) has learned that Pacific Vision Institute is promoting on its website (www.pacificvision.org) the WaveLight EX500 Excimer Laser System, 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 of any function of the body.  As described below, Pacific Vision Institute’s promotion of the WaveLight EX500 Excimer Laser System 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 EX500 Excimer Laser that 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, shall be taken into account.[1] 
 
Pacific Vision Institute’s January 2, 2013, press release, entitled “Pacific Vision Institute launches the world’s fastest excimer laser for vision correction,” available at http://pacificvision.org/in-the-news/articles/press-release-010213.html, states:
 
The WaveLight EX500 Excimer laser is the most advanced in the line of ultra fast flying spot lasers. With multiple innovations that provide customized treatments for the laser vision correction patient, the system has a laser head with a repetition rate of 500 Hz and a treatment time of 1.4 seconds per diopter, a 20% improvement over prior laser generations.  At such high speeds of correction, the WaveLight EX500 results in less patient fixation fatigue and improved patient comfort, as well as prevention of corneal drying, resulting in more precise outcomes than with any other excimer laser.
 
However, Pacific Vision Institute’s website, including the statement above, fails to reveal material facts, including relevant risk information associated with the use of the WaveLight EX500 Excimer Laser System.
 
Whether a particular advertisement or promotion is false or misleading is determined on a case‑by-case basis, and in making this determination, FDA considers many factors, including how risk information is described, displayed, and located.  However, the FDA‑approved labeling for every laser approved for LASIK includes 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 recommended the inclusion of this risk information in all advertising and promotional materials for FDA-approved lasers used for LASIK.  In addition to this common risk information, advertisements and promotion materials should include the contraindications for the particular laser that the eye care professional uses.  The contraindications for each laser can be found in the approved labeling for the laser. Moreover, eye care professionals should consider other risk information, such as warnings and precautions, in the approved labeling for the laser used by the professional to determine whether that risk information should be included in their advertisements and promotional materials.
 
As noted above, 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.htmThe labeling for each laser approved for LASIK, including theWaveLight 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.  
 
FDA requests that Pacific Vision Institute immediately cease promoting the WaveLight EX500 Excimer Laser System in violation of the Act. Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct the 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 civil money penalties.
 
Please notify this office in writing within fifteen business days from the date 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:
 
Damia Jackson
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3656
Silver Spring, Maryland 20993
 
Refer to the identification number 429833when 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: Debbie Demeritt at (301) 796-5770.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of your firm’s violations. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. 
 
 
Sincerely yours,
/S/                                                                   
Steven D. 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.  In March 2012, FDA issued letters to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology to clarify and recommend how practitioners could comply with FDA’s requirements.  See http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm297512.htm; http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm297514.htm. Those letters contain information and suggestions about how eye care practitioners can satisfy the statutory requirements related to providing risk information.
 

 

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