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. 2025 Nov 12.
doi: 10.1007/s00417-025-07012-3. Online ahead of print.

Comparing iStent complications across four generations: a manufacturer and user facility device experience (MAUDE) database study

[Article in French]
Dominic Moogon Choo #  1 , Tyler Avery Durham #  1 , Hongyi Zhang  1 , Krishna Chakravarthi Hariprasad  2 , Shivani Shashi Kamat  3
Affiliations

Comparing iStent complications across four generations: a manufacturer and user facility device experience (MAUDE) database study

[Article in French]
Dominic Moogon Choo et al. Graefes Arch Clin Exp Ophthalmol. .

Abstract

Purpose: To report real-world intraoperative and early postoperative (< 3 months) complications of iStent surgery and analyze notable examples.

Patients and methods: The Manufacturer and User Facility Device Experience database was queried for "iStent" reports from January 2014 to March 2024. Late postoperative events, reports containing inadequate detail, and those from indirect sources (e.g., published literature, social media posts) were excluded. Adverse events were analyzed per device generation.

Results: A total of 808 reports were included, revealing 437, 377, 465, and 48 adverse events across the different iStent generations. The most common intraoperative events were malposition for iStent Trabecular Micro-Bypass, Inject, and Infinite (35%, 40%, 35%) and trocar damage for Inject W (34%). Surgeons and the manufacturer most frequently cited trocar bias as the cause of trocar damage. When the timing of trocar damage was specified, 66.7% occurred during deployment of the final stent of the series. Notably, device-derived foreign body contamination was exclusive to Inject W (11). The most common early postoperative event for all four generations was elevated intraocular pressure (IOP), occurring in 32%, 38%, 15%, and 15% of cases respectively. For the Infinite, hyphema was observed at a comparable proportion (15%).

Conclusion: Post-market data highlight distinct complication profiles across iStent generations, with malposition and elevated IOP as leading reported issues. Generation-specific trends, such as trocar damage in Inject W and Infinite, underscore the need for tailored surgical vigilance and further study.

Keywords: Device malfunction; Micro-Invasive glaucoma surgery (MIGS); Post-market surveillance; Surgical technique; Trocar damage.

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Conflict of interest statement

Declarations. Compliance with ethical standards: Funded in part by a Challenge Grant from Research to Prevent Blindness, Inc. Ethical approval and informed consent: This article does not contain any studies with human participants or animals performed by any of the authors. The University of Texas Southwestern Medical Center Institutional Review Board ruled that approval was not required for this retrospective database study (STU20250901) and waived the requirement of informed consent as all data used is publicly available and does not constitute human subjects research. Consent for publication: All data used is publicly available on the FDA MAUDE website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm . Conflicts of interest: SSK has received consulting fees and honoraria from Glaukos. None of the other authors have any conflicts of interest to disclose (i.e., they have no affiliations with or involvement in any organization or entity with any financial or non-financial interest).

References

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    1. Glaukos Corporation Clinical Data for iStent infinite® In: Glaukos. https://www.glaukos.com/glaucoma/istent-infinite-clinical-data/ . Accessed 2 Mar 2025
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    1. Chen K, Pendri P, Kovacs K, Van Tassel SH (2025) Adverse events associated with devices for incisional glaucoma surgery performed with implants as reported to the FDA MAUDE database. Graefes Arch Clin Exp Ophthalmol 1–5. https://doi.org/10.1007/s00417-025-06771-3

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