Review of Optometry

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Report Your Adverse Events to the FDA

Sharing your issues through the FDA’s online voluntary reporting system is simple and could have a meaningful impact on public health and safety.
By Joseph P. Shovlin, OD

9/15/2017

When was the last time you reported a corneal ulcer from lens wear or a severe keratopathy secondary to inadvertent hydrogen peroxide instillation prior to neutralization to the Food and Drug Administration (FDA)? The answer is likely never. Fortunately, sight-threatening experiences in contact lens wearers are relatively rare. But when they do occur, there is little tolerance by the affected patient. This is especially true for family members when the patient is under the age of 18. 

For a better assessment of risk, the FDA strongly encourages voluntary reporting by healthcare providers, patients, caregivers and consumers on any significant adverse event or problem with medical products.1 

For safety’s sake
The FDA receives several hundred thousand reports of suspected device-related deaths, serious injuries and malfunctions every year.1 Occasionally, eye care providers ask me: “Am I required to report adverse events related to contact lens use or any other medical device or drug?” While the FDA’s Medical Device Reporting does not require health care professionals, including eye care providers, to report adverse events and product problems to the FDA by law, manufacturers, drug and device importers, and device user facilities are required to be mandatory reporters. 

Unfortunately, the FDA relies heavily on reports of adverse events as a part of its charge for post-market surveillance of the drugs and devices it approves each year. It uses this information to monitor drug and device performance, detect potential device-associated safety issues and contribute to risk vs. benefit assessments of drugs, devices and products.1,2 Post-market surveillance of ophthalmic devices, including contact lens and refractive laser safety, is certainly an important part of the reporting system assessment. These reports and information gleaned from other sources can provide critical information to help improve overall safety.1

Where to Report
Practitioners can–and should–report contact lens complications to the FDA through the MedWatch online voluntary reporting form for medical devices, or through the MedWatcher mobile app using a smart phone or tablet.2-3 Alerting the FDA to complications is a salient mechanism by which laws, regulations, guidelines and labeling can be updated to improve public health and safety. It is also important to note that the FDA accepts reports on any medical product.

Additionally, the FDA’s Adverse Event Reporting System is a valuable data system containing information on adverse events and medication errors that have been submitted to FDA for post-marketing drug safety surveillance. This tool helps the FDA evaluate new potential safety concerns and manufacturer’s compliance in reporting adverse events. Based on any safety concern that may arise, “the FDA may take regulatory action(s) to improve safety and protect the public.”2 Possible actions include labeling changes, restricting device or drug use, communicating new safety information to consumers or, in rare instances, removing a product from the market.2

Those who are interested can search the FDA Safety Information and Adverse Event Reporting Program database, which contains mandatory reports filed by manufacturers and importers as far back as 1996, reports filed by mandatory user facilities dating back to 1991 and voluntary reports filed as far back as 1993.1-2 While this passive surveillance system has its limitations, it still contains worthwhile information.

The next time your patient experiences an adverse event you suspect might be related to using a medical device or drug, consider reporting it to the FDA. It’s easy, relatively quick and might just provide some valuable information to both the FDA and public. In the long run, this will help improve contact lens safety as a whole.   

1. Medical Device Reporting. US Food & Drug Administration. www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. Accessed August 10, 2017.
2. Questions and Answers on FDA’s Adverse Event Reporting System. US Food & Drug Administration. www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/. Accessed August 10, 2017.
3. MedWatch Online Voluntary Reporting Form. US Food & Drug Administration. www.accessdata.fda.gov/scripts/medwatch/. Accessed August 10, 2017.





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