Abstract
PURPOSE: 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. 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 "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 (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. CONCLUSION: 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.