Int Ophthalmol. 2025 Dec 20;46(1):44. doi: 10.1007/s10792-025-03886-8.
ABSTRACT
PURPOSE: To analyze adverse events related to the Ex-Press® Glaucoma Filtration Device reported in the FDA’s MAUDE database over a 10-year period.
STUDY DESIGN: A retrospective case series.
METHODS: We retrospectively reviewed 533 unique adverse event reports submitted between January 1, 2015, and November 8, 2024. Data collected included patient demographics, reporter details, device model, event type (injury vs. malfunction), problem codes, and device availability for manufacturer evaluation. Descriptive statistics summarized patterns of device and patient problems.
RESULTS: The median patient age was 72 years (range 20-94), with sex reported in 2.3% of cases. The P-50 PL model accounted for 98% of reports, followed by the P-200 PL (2%). Devices were available for evaluation in 36.8% of cases, but only 19.3% were evaluated. Reports were 61% injuries and 39% malfunctions. A total of 440 device-related and 457 patient-related problems were identified. The most common device problems were displacement (31.4%) and flow obstruction (26.8%). Among patient problems, increased intraocular pressure (27.6%) and iris contact (22.3%) were most frequent. Injuries predominated in 2015-2016 (73.7%), shifting to malfunctions from 2020 to 2024 (76.9%).
CONCLUSIONS: Adverse events involving the Ex-Press® device primarily include injuries and malfunctions, with device displacement and flow obstruction being most common. The observed shift likely reflects changes in device use and surveillance rather than true safety changes. Despite limitations of passive reporting, these findings offer valuable real-world insights that complement clinical trial data and highlight the utility of the FDA’s MAUDE database as a tool for post-market surveillance. This approach can be replicated for other ophthalmic devices to enhance long-term safety monitoring and inform clinical decision-making.
PMID:41420769 | DOI:10.1007/s10792-025-03886-8
