Chen Qing, Yan Haijing, Chen Letong, Wang Limei, Zheng Qinxiang, Ren Yueping
National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, China.
Front Med (Lausanne). 2025 Jul 21;12:1613060. doi: 10.3389/fmed.2025.1613060. eCollection 2025.
Implantable Collamer Lens (ICL) implantation is rising globally, yet real-world studies on adverse events (AEs) remain scarce. This study analyses ICL-related complications using the MAUDE database.
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.
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 "Off-label 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 ( = 9.999 × 10, 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.
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.
可植入式Collamer晶状体（ICL）植入术在全球范围内呈上升趋势，但关于不良事件（AE）的真实世界研究仍然很少。本研究使用MAUDE数据库分析与ICL相关的并发症。
从MAUDE数据库中提取与ICL相关的AE数据。根据晶状体屈光度将病例分为球面ICL和环曲面ICL。描述性统计总结了与设备相关的问题和并发症，Cramér's V评估了它们之间的关联。还评估了常见并发症的管理策略和解决率。
在25,001例与ICL相关的AE中，43.8%涉及球面ICL，56.2%涉及环曲面ICL。常见的与设备相关的问题包括“形状和/或尺寸问题”（几乎占年度AE的一半）和“标签外使用”（约20%，自2019年以来上升并趋于稳定）。“操作和控制问题”自2019年以来稳步下降，稳定在3%以下。2019年后，出现“激活、定位或分离问题”的球面ICL病例降至1%以下，而环曲面病例则保持在6.9-9.0%。前三大并发症——“视力问题”、“眼压问题”和“晶状体相关问题”——最为常见，大多数情况下“对患者无影响”。并发症与ICL相关AE之间存在中等相关性（=9.999×10，Cramér's V：球面为0.47，环曲面为0.45）。包括晶状体置换和晶状体摘除后手术在内的管理策略显示出较高的解决率。
虽然ICL植入术总体上是安全的，但对尺寸不合适和标签外使用的担忧仍然存在。本研究表明，提高晶状体尺寸准确性并遵守指南可能会减少AE。
