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ASCRS SYMPOSIA ASCRS ASOA ANNUAL MEETING by Ellen Stodola EyeWorld Senior Staff Writer/ Meetings Editor to those 150 patients, Dr. Hern- don said that very few had issues, but there were a few who were upset about the withdrawal. Some related the symptoms they were having to this device, so it was important to offer any evaluation they were seeking, he said. Later in the session, Dr. Ey- delman commented on potential pathways for getting a device back on the market after it has been recalled. There are many examples where we work with a company and identify what the parameters were or what caused the prob- lem with the device, she said. As soon as we're comfortable that that aspect of the device has been fixed, it can return to market, she said. Editors' note: Dr. Lane has financial interests with Alcon. Dr. Talamo has financial interests with Johnson & Johnson Vision. Dr. Herndon has financial interests with Alcon. Dr. Mah has financial interests with Alcon. Drs. Eydelman and Rhee have no relevant financial interests. Dr. Mah referenced his involvement on both the ASCRS FDA Committee and the ASCRS Cornea Clinical Committee. As a member of the FDA committee, he said the goal is to represent the membership and try to represent some of the needs/wishes of the membership, as well as be a liaison with the FDA. Specifically related to the CyPass issues, Dr. Mah said that Alcon proactively provided the data and identified that they had an issue and intend- ed to withdraw the product from market. They asked for guidance for surgeons and patients, he said. Leon Herndon, MD, Durham, North Carolina, spoke about the responsibility of phy- sicians to communicate adverse events of a medical device to patients. In the case of CyPass, he had seen some 150+ CyPass devices in his practice (from about 10 different surgeons) implanted over the past 2 years. "We wanted to make sure we reached out to our patients," he said. It's prudent to put together a letter and let them know that we want to be on top of this. After sending a letter standing of the design, function, and performance of medical de- vices and to feed that information back into our everyday process, she said. Dr. Eydelman followed up with two examples of when this was used: with the recalls of the CyPass (Alcon) and the Raindrop inlay (ReVision Optics). Each of these ended up being classified as a Class 1 recall. Stephen Lane, MD, chief medical officer at Alcon, and Jonathan Talamo, MD, chief medical officer at Johnson & Johnson Vision, discussed safety issues in industry and at the com- panies they represent. Dr. Lane said that it's a credit to companies, and goes beyond ophthalmology, to get physicians who have practiced in that partic- ular field. He added that there's essentially a part of any employee contract that if you hear a person saying they have a problem with a product, there's an obligation to report it, regardless of if it seems trivial or serious. Alcon's signal program is robust and complete, he said, our goal is to make sure we follow-up on any signal we hear, see, or is reported for any of our devices. Like Alcon, Johnson & Johnson Vision has a strict policy in reporting adverse events, Dr. Talamo said. If you hear some- thing, you're obligated to relay that to the appropriate people. We don't just activate the processes when we hear something, he said, there are regular meetings to look at complaint histories, anything in the literature, and a broad range of other materials. Francis Mah, MD, La Jolla, California, and Douglas Rhee, MD, Cleveland, spoke to the role of membership societies when these concerns or recalls come up. Dr. Rhee said that though there may be no defined role, he thinks the membership will look to the society for an answer. O n Sunday afternoon, the ASCRS FDA Committee spon- sored the symposium "Communicating and Evaluating Adverse Events Associated with an FDA-Approved Medical Device." Malvina Eydelman, MD, director of the Office of Ophthal- mic, Anesthesia, Respiratory, ENT and Dental Devices, Center for Devices and Radiological Health (CDRH) at the FDA, kicked off the session by discussing the communication and evaluation of adverse events associated with an FDA-approved medical device. The FDA is responsible for evaluating and determining which devices come to market. But some people don't realize that we're also responsible for post-market sur- veillance to quickly identify poorly performing devices, she said. We are responsible for total product lifecycle at CDRH, Dr. Eydelman said. She moved on to discuss reorganization within the FDA, particularly in the CDRH, and the CDRH's medical device safety action plan. CDRH's vision for medical device safety is to pro- tect patients and spur innovation of new products that are safer, more effective, and address unmet medical needs. Dr. Eydelman also discussed the signal management program associated with the medical device safety action plan. Signal manage- ment aims to promote and protect public health by proactively identi- fying, evaluating, and expeditiously managing emerging risks as early as possible with the hope of pro- moting the safest possible use of marketed medical devices. Signal management also aims to provide the CDRH with a better under- FDA symposium covers adverse events associated with approved medical devices Natalie Afshari, MD, moderates the FDA symposium on Sunday afternoon, which also featured Dr. Rhee, Dr. Mah, and Dr. Lane. 44 | EYEWORLD DAILY NEWS | MAY 7, 2019

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