Adverse Events Reporting
The ASRS Research and Safety in Therapeutics (ReST) Committee is dedicated to keeping you apprised of adverse events (AEs) associated with all retina drugs and devices. Our peer-to-peer reporting system serves as a post-market data and safety monitor to help protect patients.
The committee works closely with the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to identify and investigate AEs.
The ReST Committee has investigated numerous AEs and has alerted ASRS members about events ranging from cases of ocular inflammation/noninfectious endophthalmitis following intravitreal injections to cases of suspected fungal endophthalmitis following adjuvant-assisted vitrectomy procedures.
Here's How to Report AEs to the ReST Committee
If any of your patients experience an adverse event, report it to the ReST Committee as soon as possible. A ReST Committee member will follow up with you, work with industry where appropriate, and assess whether the situation warrants an alert to ASRS members.
For all cases reported using the online HIPAA-compliant form linked below, the case submitter must review and attest to the following ReST case agreements:
- Case Submission and Data Reporting Agreement: Allows ASRS to receive, use and disclose a limited data set in accordance with HIPAA.
- ReST Case Data Use Agreement: Governs how the ASRS can use de-identified derivates of the ReST case data.
Click to report an adverse event
In addition, please report all adverse events to the manufacturer and FDA Medwatch.
ReST Committee Members
- Andre J. Witkin, MD, Chair
- Ferhina S. Ali, MD, MPH, FASRS
- Sruthi Arepalli, MD
- Durga Borkar, MD
- Jordon D. Deaner, MD
- Nieraj Jain, MD, FASRS
- Nikolas JS London, MD, FACS, FASRS
- Akshay S. Thomas, MD, MS, FASRS
- Eric W. Schneider, MD, FASRS
- Ivan J. Suner, MD, MBA
- Lejla Vajzovic, MD, FASRS
- Robin A. Vora, MD
ReST Committee Update on Intraocular Inflammation After IVI
The ASRS ReST Committee and Executive Committee thoroughly investigate and vet reports of adverse events and disseminate relevant information to members to ensure patient safety.
To report a potential adverse event
- Complete the ASRS Adverse Event Report Form
- Complete the FDA Medwatch Voluntary Reporting Form
- ReST News