Adverse Events Associated With Yamane Scleral Fixation of Intraocular Lens as Reported to the FDA MAUDE Database.

Overview

To identify real-world complications involving flanged scleral tunnel fixation of Zeiss CT Lucia 602 intraocular lenses, the Food and Drug Administration Manufacturer and User Facility Device Experience (FDA MAUDE) was searched by Manufacturer field for Zeiss with the terms "Ya-mane" and "scleral fixated". Reports containing these terms were reviewed to confirm technique and categorize adverse events. The search yielded 178 confirmed reports of lens malfunctions for CT Lucia 602 between 2013 to 2024, with 95% of reports in the last 3 years. The most common complication was lens tilt (94 reports), followed by breakage (53) comprised of haptic-optic disinsertion (31) and haptic breakage (22). Intraoperatively, 118 (66.3%) complications occurred, and 60 (33.7%) occurred postoperatively. Temporal analysis revealed that the number of reports to MAUDE has shown a ten-fold annual increase since 2020. Reports suggest haptic breakage is a noteworthy malfunction for CT Lucia 602 lenses. The occurrence of intraoperative breakage and lens tilt may be higher than previously expected in real-world settings. [Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.].