Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives— 510(k) K153643

Substantially Equivalent

Alcon Laboratories, Inc.

FDA 510(k) clearance K153643 for Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives, Substantially Equivalent on 2016-01-20. Applicant: Alcon Laboratories, Inc..

Clearance details

Applicant: Alcon Laboratories, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2015-12-21
Decision date: 2016-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Worth, TX, US

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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.