Journal of cataract and refractive surgery · 2026
Retrospective analysis of U.S. Food and Drug Administration recalls of artificial tear solutions from 2014 to 2025.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Bhattacharya Aishwarya, Kang Paul C
Аннотация
PURPOSE: To examine all recalls of artificial tears from 2014 to 2025 to identify the most common types, classes of products, and associated reasons for recalls, and to provide guidance on safety.
SETTING: United States.
DESIGN: Retrospective epidemiologic assessment.
METHODS: Artificial tear recalls from January 2014 to August 2025 were identified through the U.S. Food and Drug Administration Enforcement Report. Data on country of manufacture, classification, ingredients, preservative use, and recall reason were analyzed. The primary end points of the study were the most common causes of recall, and the types of products associated with each recall. Secondary end points included classification of recall reasons, common ingredients associated with recalls, and the country where the product was manufactured.
RESULTS: 110 unique formulations of recalled tears were identified. Most recalls were class II (81) linked to lack of assurance of sterility (65) that could cause reversible adverse health outcomes and class I (26) due to microbial contamination (25) that could cause permanent adverse outcomes. Preserved (48) and preservative-free tears (62) were similarly implicated (χ 2 (3, N = 110) = 6.71, P = .082). Most recalled tears were manufactured in the United States (85) and were generic formulations (80).
CONCLUSIONS: Most recalled tears were U.S. generics recalled because of lack of sterility. Preservative-free and preserved tears had similar recalls. Overall, recalls tied to confirmed microbial contamination of tears remain rare compared with their prolific use in the U.S.
SETTING: United States.
DESIGN: Retrospective epidemiologic assessment.
METHODS: Artificial tear recalls from January 2014 to August 2025 were identified through the U.S. Food and Drug Administration Enforcement Report. Data on country of manufacture, classification, ingredients, preservative use, and recall reason were analyzed. The primary end points of the study were the most common causes of recall, and the types of products associated with each recall. Secondary end points included classification of recall reasons, common ingredients associated with recalls, and the country where the product was manufactured.
RESULTS: 110 unique formulations of recalled tears were identified. Most recalls were class II (81) linked to lack of assurance of sterility (65) that could cause reversible adverse health outcomes and class I (26) due to microbial contamination (25) that could cause permanent adverse outcomes. Preserved (48) and preservative-free tears (62) were similarly implicated (χ 2 (3, N = 110) = 6.71, P = .082). Most recalled tears were manufactured in the United States (85) and were generic formulations (80).
CONCLUSIONS: Most recalled tears were U.S. generics recalled because of lack of sterility. Preservative-free and preserved tears had similar recalls. Overall, recalls tied to confirmed microbial contamination of tears remain rare compared with their prolific use in the U.S.