Inspections, Compliance, Enforcement, and Criminal Investigations
Rand Eye Institute 12/18/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
DEC 18, 2012
William J. Rand, M.D.
Medical Director and Founder
Rand Eye Institute
5 West Sample Road
Deerfield Beach, Florida 33064
Dear Dr. Rand:
The Food and Drug Administrative (FDA) has learned that the Rand Eye Institute is promoting on its website (www.randeye.com) the VISX Star S4 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, Rand Eye Institute’s promotion of the VISX Star S4 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 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
Rand Eye Institute’s website, “CustomVue LASIK,” available at http://www.randeye.com/LSV/LSV/CustomVue-LASIK.html, states:
There are two parts to the Rand Eye Institute VISX WavePrint System.
First, it includes a diagnostic device that maps the entire optical path of your eye. This WavePrint™ Map, called the “fingerprint of your vision,” provides the doctor with precise and detailed information about your vision.
Secondly, the WavePrint System incorporates the VISX S4 IR™ laser from VISX with two exclusive features: Variable Spot Scanning and 3D ActiveTrak™ technology. Variable Spot Scanning (VSS™) allows for a larger treatment area and offers the physician greater flexibility in developing a more personalized laser vision procedure, when pupil size may be a consideration.
3D ActiveTrak automatically and instantaneously tracks the minute movements of your eye in all three dimensions during the laser treatment. This unique feature means you no longer have to hold your eye perfectly still, but can relax, knowing your treatment is precisely centered on your eye.
Moreover, when discussing the results patients should expect the website states:
Everyone is different. Most LASIK patients no longer need glasses or contacts while driving, playing sports or watching movies and television. People pursuing careers that require excellent vision—such as police officers, paramedics, physicians and athletes—have benefited greatly from LASIK.
Rand Eye Institute website, “LASIK,” at p. 4 available at http://www.randeye.com/laser_vision_correction/LASIK/LASIK_p4.html.
However, Rand Eye Institute’s website fails to reveal material facts, including relevant risk information associated with the use of the VISX Star S4 IR™ 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 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 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 the Rand Eye Institute immediately cease promoting 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:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
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.
Office of Compliance
Center for Devices and
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;
2 A clinic's use of a device in patient treatment constitutes ·'holding for sale.'' See. e.g., UnitedStatesv. Diapulse Corp. of Am., 514 F.2d 1097, 1098 (2d Cir. 1975).