Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens— 510(k) K143632

Substantially Equivalent

Bausch & Lomb, Incorporated

FDA 510(k) clearance K143632 for Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens, Substantially Equivalent on 2015-02-13. Applicant: Bausch & Lomb, Incorporated.

Clearance details

Applicant: Bausch & Lomb, Incorporated
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2014-12-22
Decision date: 2015-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.