Visual Symptoms and Optic Clarity Disturbances Associated With Intraocular Lenses in U.S. Food and Drug Administration Device Reports.

Authors

Idan Hecht, Ruti Sella, Piotr Kanclerz, Raimo Tuuminen

Published in

Journal of refractive surgery (Thorofare, N.J. : 1995). Volume 42. Issue 9. Pages e968-e977. Epub Sep 01, 2026.

Abstract

To characterize postoperative visual symptoms and optic clarity issues across intraocular lens (IOL) types, reported in U.S. Food and Drug Administration (FDA) device reports.
A retrospective observational analysis of FDA Manufacturer and User Facility Device Experience (MAUDE) reports on visual symptoms and/or IOL optic clarity issues, from January 1, 2016 through December 31, 2025. Structured MAUDE fields served as the primary data source, with report narratives analyzed using automated natural language processing to supplement classification.
A total of 17,204 postoperative MAUDE reports met inclusion criteria (16,198 with visual symptoms and 2,510 with clarity issues; both present in 1,504 reports). Multifocal and extended depth of focus (EDOF) IOLs showed a higher proportion reporting of visual symptoms than monofocal IOLs (97.5%, and 98.6% vs 85.5%, respectively, P < .001) and specifically glare (21.8% and 24.8% vs 8.6%, P < .001) and halos (29.7% and 30.1% vs 8.6%, P < .001). Clarity issues were reported more frequently in monofocal IOLs than in multifocal and EDOF IOLs (27.8% vs 11.0% and 8.8%, P < .001). Overall, clarity issues were reported later than visual symptoms (64.9 ± 72.6 vs 7.9 ± 20.9 months, P < .001), and visual symptoms more often required IOL exchange than clarity issues (62.9% vs 20.8%, P < .001).
In MAUDE postoperative reports, multifocal and EDOF IOLs had a higher proportion of visual symptoms and specifically glare and halos, whereas monofocal IOLs had a higher proportion of later reported clarity issues. These findings reflect differences in reported events rather than population-level risk and may inform post-market surveillance priorities.

PMID:
42715022
Bibliographic data and abstract were imported from PubMed on 10 Sep 2026.

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