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1 December 27, 2011 Steven Silverman, Director Office of Compliance Food and Drug Administration Center for Devices and Radiological Health New Hampshire Avenue Silver Spring, Maryland Dear Mr. Silverman: LASIK Surgery Watch (LSW), a non-profit LASIK patient advocacy organization, is writing to report LASIK advertising violations by Kim Robbins, M.D. of Bridgeport, CT. Dr. Robbins is in violation of the Federal, Food, Drug, and Cosmetic Act as it applies to false or misleading advertising of a restricted medical device (the laser used to perform LASIK) and consumer protection laws under Federal Trade Commission jurisdiction. We enclose 2 pages printed from Dr. Robbins website located at accessed on December 8, Dr. Robbins advertises LASIK with two specific medical devices: Allegretto Wave excimer laser and IntraLase femtosecond flap-cutting laser. As you can see, there is a vague mention of certain medical conditions, but no warning of potential complications and adverse events. The website content gives the impression that LASIK is virtually risk-free. Furthermore, there is no mention of the possibility that a patient may require glasses or contact lenses after LASIK, either immediately or in the future. Moreover, the following false statement is found on the webpage: Dr. Robbins was one of the original 200 surgeons initially approved nationwide to perform LASIK upon the procedures approval by the FDA in Dr. Robbins is endangering the public health through misleading LASIK advertising, which fails to reveal known facts about risks and adverse surgical effects. In consideration of this complaint, we enclose a 34 page Consent Order issued November 22, 2011 by the Connecticut Department of Health citing Robbins Eye Center Box 91381, Raleigh, NC

2 Steven Silverman December 27, 2011 Page 2 of 2 for wrong eye surgery, inadequate sanitation in the operating room, inadequate medical follow-up and monitoring after surgery, and questionable credentials of medical staff. LSW members request that the FDA take immediate action to stop deceptive and misleading advertising of LASIK by Kim Robbins, M.D, using all remedies available to the agency. Sincerely, Lauranell H. Burch, Ph.D. Chair LASIK Surgery Watch Matthew Kotsovolos, CPA Treasurer LASIK Surgery Watch Natalie A. Messier Secretary LASIK Surgery Watch cc: Jeffrey Shuren, M.D., J.D. Director, Center for Devices & Radiological Health U.S. Food & Drug Administration Center for Devices and Radiological Health Office of the Center Director New Hampshire Avenue WO Silver Spring, MD David Vladeck Director, Bureau of Consumer Protection Federal Trade Commission 600 Pennsylvania Avenue Washington, D.C Box 91381, Raleigh, NC

3 Robbins Eye Center Page 1 of 2 12/8/ Main Street, Bridgeport, CT LASIK: A Personal Choice We understand that making the choice to shed your glasses or contacts is a highly personal decision. Our patients have chosen LASIK for a myriad of reasons. People like policemen, firemen, doctors and artists often tell us they find their glasses and contacts a professional limitation. Athletes, amateur and professional, choose LASIK to elevate their game. Others choose LASIK to improve their daily quality of life from being able to see the alarm clock from bed in the morning to jumping in the swimming pool with the kids. Whatever your reason for choosing LASIK, Dr. Robbins and her team will develop a personalized treatment plan tailored to your needs. Are You A Good Candidate? You should be at least 21 years old, since the vision of younger people usually continues to change. Your eyes must be healthy and your prescription stable. People with certain medical conditions and pregnant or nursing women may not be good candidates, as these conditions sometimes temporarily change the shape of the eye. LASIK Consultation and Exam If you meet the above criteria, the next step is to make an appointment for a free initial consultation to determine if vision correction surgery is a viable option for you. Upon confirmation of your treatment viability, you may make an appointment to have an in depth examination in order for Dr. Robbins to develop your personal LASIK care plan tailored to your specific needs. USE YOUR HEALTH SAVINGS ACCOUNT TO SAVE ON LASIK Did you know that using your Flexible Spending Account or Healthcare Savings Account can save you up to 30% on LASIK? Please call us at for details or fill out the form below and we will call you back during business hours to schedule your free consultation. Business hours are: Monday - Friday / 8am - 5pm Name * First ### - Last Phone Number * * ### - #### Robbins Eye Care Newsletter Yes, sign me up for the monthly newsletter Caring, Personal Attention for Each Patient Dr. Robbins is the only physician who performs laser vision correction surgeries at the Robbins Eye Center and is committed to providing a safe and comfortable experience for each patient. Dr. Robbins is with you through every step of the process, from initial examination through surgery to all follow up care. Experience: Our Medical Director, Dr. Kim Robbins, is one of the pioneers of LASIK vision correction. Dr. Robbins was one of the original 200 surgeons initially approved nationwide to perform LASIK upon the procedures approval by the FDA in Since then, Dr. Robbins has performed over 8,000 LASIK procedures for patients that have traveled to the Robbins surgery center from all over the world. Allegretto Wave Eye-Q: The Allegretto laser is the newest refractive laser approved for use in the United States. It is the safest and most accurate laser available for patients today and

4 Robbins Eye Center Page 2 of 2 12/8/2011 the Robbins Eye Center is the first in Connecticut to use this technology. With a reliable eye tracker and predictable results, this laser enables more patients than ever before to experience high-performance vision after one short, comfortable treatment usually less than 15 seconds long! This next generation LASIK surgery is approved for nearsightedness and astigmatism in cases twice as severe as before. The Allegretto wave laser is the only FDA-approved laser that can use wavefront technology on farsighted patients. In FDA trials, 44% of farsighted participants could see better after the procedure than with glasses or contacts. It's even designed to treat patients with severe myopia and hyperopia! You will be at ease to know that Dr. Robbins has performed more no-blade Allegretto wave LASIK procedures than all other eye doctors in Connecticut combined. You can have confidence in Dr. Robbins' LASIK skill and extensive experience. Intralase: Dr. Robbins only performs LASIK using the state-of-the-art Intralase. Intralase allows for greater safety and patient comfort by eliminating the use of a blade in order to create a LASIK flap. In other words, every LASIK patient get a bladeless experience. Stay Connected Privacy Contact Us Robbins Eye Center 4695 Main Street, Bridgeport, CT , Robbins Eye Center. ALL RIGHTS RESERVED.

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