Adverse events of trabecular micro-bypass minimally invasive glaucoma surgery devices: a five-year analysis from the FDA MAUDE database

Int Ophthalmol. 2025 Nov 18;45(1):493. doi: 10.1007/s10792-025-03866-y.

ABSTRACT

BACKGROUND: In 2020, 76 million people around the world had glaucoma, and by 2040, that number is predicted to rise to 111.8 million. Minimally invasive glaucoma surgery (MIGS) has become an effective method to treat open-angle glaucoma. It lowers the pressure inside the eye by improving the drainage mechanism of the eye's aqueous humor. MIGS devices, such as the iStent® and Hydrus®, aid in aqueous outflow and patency maintenance. However, their long-term safety and efficacy require ongoing post-market surveillance across diverse patient populations. It's important to know how safe implanted devices like MIGS are over a long period of time.

OBJECTIVE: To conduct a five-year retrospective analysis of adverse events associated with the Hydrus® Microstent and iStent® trabecular micro-bypass MIGS devices, as reported in the U.S. Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database, and to characterize the spectrum and reporting patterns of device- and patient-related complications to better define their real-world safety profile in glaucoma management.

STUDY DESIGN: A retrospective case-series.

METHODS: All MAUDE reports submitted between January 1, 2020, and October 31, 2024, containing product codes "OGO" and "KYF" were screened. A total of 784 eligible reports involving Hydrus and various iStent models were analyzed for device-related and patient-related adverse events. Descriptive statistics were used to summarize event types and frequencies. Heatmaps and visualizations were also created using Python Google Colab.

RESULTS: Among 784 reports, injuries accounted for 63.1% of cases, and malfunctions for 36.9%. A total of 503 device-related and 1,012 patient-related problems were identified. Among device-related problems, malposition was the most commonly reported issue (37.3% of device problem reports), followed by breakage (23.5%) and obstruction (9.0%). Frequent patient-related events included increased IOP (19.4%), hyphema (12.1%), and foreign body in patients (10.6%). Among Hydrus®-related reports, malposition was the most frequently reported device issue; among iStent® Inject W reports, breakage predominated.

CONCLUSION: The Hydrus® and iStent® trabecular micro-bypass MIGS devices have shown generally favorable safety over five years of postmarket surveillance. However, device malposition and mechanical failures were frequently reported in voluntary submissions, though, due to the absence of denominator data, these reports cannot be interpreted as evidence of higher real-world incidence compared to clinical trials. These findings inform surgical training, patient counseling, and highlight the need for prospective real-world registries to establish true complication rates.

PMID:41251818 | DOI:10.1007/s10792-025-03866-y