Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism— 510(k) K200528

Substantially Equivalent

Bausch + Lomb, Incorporated

FDA 510(k) clearance K200528 for Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism, Substantially Equivalent on 2020-06-02. Applicant: Bausch + Lomb, Incorporated.

Clearance details

Applicant: Bausch + Lomb, Incorporated
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2020-03-02
Decision date: 2020-06-02
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.