Adverse events associated with Implantable Collamer Lens: insights from the FDA MAUDE database

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 (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.

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.