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Adverse Events Associated with Devices for Incisional Glaucoma Surgery Performed with Implants as Reported to the FDA
Kaylie Chen1, Pooja Pendri1, Kyle Kovacs1
1Israel Englander Department of Ophthalmology, Weill Cornell Medical College, 1305 York Avenue, 11th Floor, New York, NY, USA.
Summary
This study analyzed Food and Drug Administration (FDA) data on incisional glaucoma surgery devices. It identified common complications like hypotony and device-iris touch to improve patient counseling and surgical preparation.
Area of Science:
- Ophthalmology
- Medical Device Safety
- Glaucoma Surgery
Background:
- Incisional glaucoma surgery with implants is crucial for advanced or refractory glaucoma.
- The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database offers real-world complication data.
- Analyzing MAUDE data can establish risk profiles for different glaucoma surgery devices.
Purpose of the Study:
- To identify and categorize complications associated with specific incisional glaucoma surgery devices using FDA MAUDE data.
- To develop a risk profile for commonly used glaucoma drainage and filtration devices.
- To provide insights into real-world device performance and adverse events.
Main Methods:
- Searched the FDA MAUDE database from January 2012 to December 2021.
- Included specific brands: Ahmed ClearPath, Ahmed Glaucoma Valve, Baerveldt, Ex-PRESS, and Molteno.
- Categorized reports by complication, excluding duplicates and non-specific comparative literature.
Main Results:
- 1379 reports detailing 2429 adverse events met inclusion criteria.
- Most frequent complications included hypotony/hypotony maculopathy (284), device-iris touch (282), and device occlusion (213).
- Other significant events: elevated intraocular pressure (IOP) (210), device explantation (176), delivery system failures (166), and corneal issues (128).
Conclusions:
- The study highlights the most clinically relevant adverse events for incisional glaucoma surgery devices based on real-world data.
- Findings can aid surgeons in patient counseling and pre-operative planning for device implantation.
- Understanding device-specific complications enhances surgical decision-making and patient safety.
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