Adverse Events Associated with Devices for Incisional Glaucoma Surgery Performed with Implants as Reported to the FDA MAUDE Database.
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Abstract
PURPOSE: Incisional glaucoma surgery is indicated in advanced glaucoma or glaucoma refractory to less invasive therapies, and can be performed with implants to lower IOP including glaucoma drainage or filtration devices. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) represents the largest U.S. publicly-available repository of device-related incisional glaucoma surgery complications, enabling insight into complications experienced with incisional glaucoma surgery in real-world practice to develop a risk profile for the use of each device. METHODS: MAUDE database was searched between January-2012 and December-2021 for Brand Name: Ahmed ClearPath, Ahmed Glaucoma Valve, Baerveldt, Ex-PRESS, and Molteno. Reports were categorized by complication;when multiple were present, multiple categories were attributed. Reports with identical text and dates were counted as duplicate and excluded. Literature reports comparing multiple devices without clear device specification per complication were excluded. RESULTS: The search yielded 1538 reports, of which 1379 reports describing 2429 adverse events met inclusion criteria. The most common events for were hypotony/hypotony maculopathy (284), device-iris touch (282), device occlusion (213), elevated IOP (210), and device explanted due to possible exclusion (176). Delivery system failures occurred (166). Patients also experienced flat/shallow anterior chambers (147) and corneal edema/bullous keratopathy/endothelial cell count reduction/corneal decompensation/Descemet's membrane tears (128). CONCLUSION: By drawing on the real-world complications collected in the MAUDE database, this study identifies adverse events of greatest clinical pertinence for device-related incisional glaucoma surgery overall and by brand. Understanding the most common adverse events may support surgeons in counseling patients and preparing for device implantation.