Adverse Events Associated With 3 Vitrectomy Platforms Reported to the US FDA MAUDE Database.

Purpose: To identify and describe adverse events (AEs) observed with real-world use of the following 3 vitrectomy platforms: Constellation (Alcon), Enhancing Visual Acuity (EVA, Dutch Ophthalmic Research Center), and Stellaris (Bausch + Lomb). Methods: All reports submitted to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database between January 2010 and November 2021 that were associated with the 3 vitrectomy platforms were analyzed. Each report was reviewed for AEs or consequences and the type of complication noted. Duplicates and reports with an inadequate narrative to categorize the event were excluded. A descriptive analysis was performed for the prevalence of device-specific issues within each platform. Results: The analysis included 2534 reports (1738 Constellation, 117 EVA, 679 Stellaris). Overall, the most commonly reported complications involved the vitrectomy probe (n = 957 [37.8%]) and the central processing unit (n = 368 [14.5%]). Differences in the distribution of AEs among the platforms were noted, with vitrectomy probe issues being the most reported events for the Constellation and Stellaris and infusion issues for the EVA. Infusion issues most frequently led to reports of patient harm with the Constellation (31/1738 [1.8%]) and EVA (7/116 [6.0%]), while issues with the vitrectomy probe were reported with the Stellaris (11/679 [1.6%]). Conclusions: An analysis of real-world data in the MAUDE database highlighted the spectrum of device-specific AEs of greatest relevance to surgical practice. Familiarity with potential device complications will help minimize harm to patients.
Competing Interests: Dr. Kovas: Intergalactic Therapeutics (consultant). Dr. D’Amico: Alcon, Iveric Bio, and Aufbau Holdings (consultant); Iveric Bio and Aufbau Holdings (equity); Aufbau Holdings (intellectual property). Dr. Van Tassel: Alcon, Adverum, Abbvie, Equinox, New World Medical, Glaukos, Belkin, Bausch + Lomb, Zeiss, Character Biosciences, and Thea (consultant); Equinox (equity). Dr. Kiss: Adverum, Alcon, Novartis, Optos, and Genentech/Roche (consultant); Allergan, Novartis, Optos, Genentech/Roche, and Regeneron (research funding); Adverum, RegenxBio, and Fortress Bio (equity); gene therapy for age-related macular degeneration and T cells for CMV retinitis, assigned to Cornell University (intellectual property). Drs. D’Amico and Kiss reported that their consulting their consulting roles with Alcon had no bearing on the conception of this study, interpretation of the data retrieved from the MAUDE database, or composition of the manuscript. No discussion with third parties was held regarding the content of this manuscript, and the author(s) declared that their interpretation and analysis are solely their own. Authors with ongoing relationships with entities described in the manuscript were not involved in data acquisition, classification, or primary analysis. None of the other authors declared potential conflicts of interest with respect to the research, authorship, and/or publication of the article.
(© The Author(s) 2024.)