Abstract
INTRODUCTION: To evaluate and characterize adverse events (AEs) associated with EVO and EVO+ implantable collamer lens (ICL) using real-world post-marketing surveillance data from the Food and Drug Administration (FDA)'s MAUDE database. METHODS: A retrospective analysis was conducted on AE reports related to EVO and EVO+ ICLs, including both spherical and toric models, submitted between 2015 and 2023. After excluding duplicate entries and incomplete records, reports were stratified by lens model and optical type into four groups: spherical EVO, toric EVO, spherical EVO+, and toric EVO+. Each report was independently reviewed by two senior ophthalmologists to classify the associated complications. Descriptive statistics were used to evaluate the proportional distribution of complications across subgroups and to assess the annual trend in reported AEs. RESULTS: A total of 17,482 AEs reports were analyzed. Across all subgroups, over half of the reports documented no clinical signs or symptoms. Blurred vision was the most frequently reported visual complaint, with a relatively higher reporting frequency in the EVO+ groups. Events involving elevated intraocular pressure and glaucoma were more commonly reported among EVO+ recipients. In addition, a number of rare but clinically significant complications were documented, including hemorrhage, hyphema, decreased intraocular pressure, endophthalmitis, and toxic anterior segment syndrome. The annual number of reported AEs showed a consistent upward trend throughout the study period. CONCLUSION: This real-world data analysis provides insights into the distribution of major complications associated with ICL implantation in clinical practice. Comprehensive identification and reporting of rare adverse outcomes may help surgeons broaden their perspectives, enhance surgical preparedness, and provide more personalized and informed preoperative counseling.