510(k) K112192— NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS

Substantially Equivalent

Bausch & Lomb, Inc.

Clearance details

Applicant: Bausch & Lomb, Inc.
Product code: Code MVN
Advisory panel: Ophthalmic
Date received: 2011-07-29
Decision date: 2011-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Adverse events under product code MVN

product code MVN

Injury: 149
Total: 149

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.