ORIGINAL RESEARCH article
Front. Med.
Sec. Ophthalmology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1613060
This article is part of the Research TopicA focus on the past, present and future of lens researchView all articles
Adverse Events Associated with Implantable Collamer Lens : Insights from the FDA MAUDE Database
Provisionally accepted
- Affiliated Eye Hospital to Wenzhou Medical University, Wenzhou, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Purpose: Implantable Collamer Lens (ICL) implantation is rising globally, yet real-world studies on adverse events (AEs) remain scarce. This study analyzes ICL-related complications using the MAUDE database. Methods: Data on ICL-related AEs were extracted from the MAUDE database.Cases were categorized into spherical and toric ICLs based on lens diopter. Descriptive statistics summarized device-related issues and complications, and Cramér's V assessed their associations.Management strategies and resolution rates for common complications were also evaluated. Results: Among 25,001 ICL-related AEs, 43.8% involved spherical ICLs and 56.2% toric ICLs. Common device-related issues included "Shape and/or size problems" (nearly half of annual AEs) and "Offlabel use" (around 20%, rising since 2019 and stabilizing). "Operation and control issues" declined steadily since 2019, stabilizing below 3%. Spherical ICL cases with "Activation, positioning, or separation problems" dropped below 1% post-2019, while toric cases remained at 6.9-9.0%. The top three complications-"Vision issues", "Intraocular pressure issues" and "Lens-related issues"-were most frequent, with "No patient impact" in most cases. Moderate correlations were found between complications and ICL-related AEs (p = 9.999 × 10⁻⁵, Cramér's V: 0.47 for spherical, 0.45 for toric). Management strategies, including lens exchange and lens extraction followed by surgery, demonstrated high resolution rates. Conclusions: While ICL implantation is generally safe, concerns about inappropriate sizing and off-label use persist. This study suggests that improving lens sizing accuracy and adhering to guidelines may reduce AEs.
Keywords: FDA MAUDE database, adverse events, Toric implantable collamer lens, retrospective analysis, spherical Implantable Collamer Lens. (Min.5-Max. 8)
Received: 16 Apr 2025; Accepted: 09 Jul 2025.
Copyright: © 2025 Chen, Yan, Chen, Wang, Zheng and Ren. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Qinxiang Zheng, Affiliated Eye Hospital to Wenzhou Medical University, Wenzhou, China
Yueping Ren, Affiliated Eye Hospital to Wenzhou Medical University, Wenzhou, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.