Journal of cataract and refractive surgery · 2026
Preloaded vs manually loaded intraocular lens delivery failure modes: an analysis of Food and Drug Administration device reports.
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Hecht Idan, Tuuminen Raimo, Kanclerz Piotr, Sella Ruti
Аннотация
PURPOSE: To compare reported intraoperative failure-mode profiles between preloaded and manually loaded intraocular lens (IOL) delivery systems using U.S. Food and Drug Administration (FDA) device reports.
SETTING: FDA Manufacturer and User Facility Device Experience (MAUDE) database, United States.
DESIGN: Retrospective cross-sectional study.
METHODS: MAUDE reports from January 1, 2016 through December 31, 2025 were reviewed. Reports describing intraoperative IOL loading, delivery, or positioning issues were included when injector type was specified. Structured MAUDE fields served as the primary data source, and free-text narratives were analyzed using automated natural language processing to supplement classification when consistent with structured fields. Comparisons were performed using within-group proportions, and multivariable logistic regression estimated adjusted odds ratios (aORs) controlling for report year, manufacturer, lens platform, and reporting entity.
RESULTS: Of 57,435 FDA device reports, 14,460 intraoperative reports met inclusion criteria; 10,567 (73.1%) involved preloaded systems and 3,893 (26.9%) manually loaded systems. Manually loaded systems showed higher reporting of IOL damage (66.0% vs 45.4%; aOR 3.06, 95% CI 2.78-3.37; p<0.001) and loading issues (aOR 5.53, 95% CI 3.99-7.66; p<0.001). Preloaded systems showed higher reporting of delivery failures (40.5% vs 21.8%; aOR 3.91, 95% CI 3.51-4.35; p<0.001), lens positioning issues (aOR 1.27, 95% CI 1.01-1.62; p=0.041), and material or optics abnormalities (aOR 3.53, 95% CI 1.96-6.35; p<0.001).
CONCLUSIONS: Preloaded and manually loaded IOL delivery systems demonstrated distinct failure-mode profiles within FDA device reports. These findings characterized reporting patterns rather than population-level risk and may inform device design and post-market surveillance priorities.
SETTING: FDA Manufacturer and User Facility Device Experience (MAUDE) database, United States.
DESIGN: Retrospective cross-sectional study.
METHODS: MAUDE reports from January 1, 2016 through December 31, 2025 were reviewed. Reports describing intraoperative IOL loading, delivery, or positioning issues were included when injector type was specified. Structured MAUDE fields served as the primary data source, and free-text narratives were analyzed using automated natural language processing to supplement classification when consistent with structured fields. Comparisons were performed using within-group proportions, and multivariable logistic regression estimated adjusted odds ratios (aORs) controlling for report year, manufacturer, lens platform, and reporting entity.
RESULTS: Of 57,435 FDA device reports, 14,460 intraoperative reports met inclusion criteria; 10,567 (73.1%) involved preloaded systems and 3,893 (26.9%) manually loaded systems. Manually loaded systems showed higher reporting of IOL damage (66.0% vs 45.4%; aOR 3.06, 95% CI 2.78-3.37; p<0.001) and loading issues (aOR 5.53, 95% CI 3.99-7.66; p<0.001). Preloaded systems showed higher reporting of delivery failures (40.5% vs 21.8%; aOR 3.91, 95% CI 3.51-4.35; p<0.001), lens positioning issues (aOR 1.27, 95% CI 1.01-1.62; p=0.041), and material or optics abnormalities (aOR 3.53, 95% CI 1.96-6.35; p<0.001).
CONCLUSIONS: Preloaded and manually loaded IOL delivery systems demonstrated distinct failure-mode profiles within FDA device reports. These findings characterized reporting patterns rather than population-level risk and may inform device design and post-market surveillance priorities.