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

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...