Abstract
Purpose :
The Yamane technique continues to grow in popularity due to excellent reported outcomes but requires considerable skill to avoid haptic breakage or disinsertion. Device malfunction reports provide real-world experience by surgeons employing this technique. We identified real-world complications involving flanged scleral tunnel fixation of three-piece intraocular lenses (IOLs) reported to the FDA MAUDE database.
Methods :
MAUDE database was searched by Manufacturer field for terms: Alcon, Bausch and Lomb, Zeiss, Aaren Scientific, Johnson and Johnson with the terms “Yamane” and “scleral fixated.” Resulting data included report number, event date, report date, manufacturer, lens model, malfunction timing, and event description. Reports were reviewed to confirm Yamane or flanged intrascleral haptic fixation was utilized. Malfunction was categorized by descriptive report as haptic breakage or haptic disinsertion; timing was categorized as intraoperative or postoperative.
Results :
Database search yielded 64 established reports of lens malfunctions for the Zeiss CT Lucia/EC3-PAL lens. Significantly fewer reports existed for similar other multi-piece IOLs lenses. Of the 64 reports for the Zeiss CT Lucia/EC3-PAL, the most common complication was lens tilt (36) followed by breakage (21). Of the breakages, 15 were categorized as haptic-optic disinsertion and 6 as haptic breakage. Other complications included 3 reports of haptic bent lenses, 3 haptic dislocations, and 1 stuck haptic. Notably, 40 (62.5%) of complications occurred intra-operatively and 24 (37.5%) post-operatively. Breakage and bent lenses were predominant in the intra-operative reports. Reports of lens tilt were split between intra- (52.8%) and post-operative (47.2%) reports. The number of reports made to MAUDE has risen since 2020 and throughout the following years with the peak number of reports during Dec 2022 at 14 (Figure 1).
Conclusions :
The distribution of reported malfunctions suggests that haptic breakage is a noteworthy malfunction for Zeiss CT Lucia/EC3-PAL lenses and occurrence of intra-operative breakage may be higher than previously expected in real-world practice settings. Other complications such as lens tilt may also be higher in real-world settings both during and after the operation. Surgeons should be aware of real-world complications so appropriate training and preparation can occur.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.