BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT— 510(k) K011718

Substantially Equivalent

Bausch & Lomb, Inc.

FDA 510(k) clearance K011718 for BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT, Substantially Equivalent on 2001-07-25. Applicant: Bausch & Lomb, Inc..

Clearance details

Applicant: Bausch & Lomb, Inc.
Product code: Code MVN
Advisory panel: Ophthalmic
Date received: 2001-06-04
Decision date: 2001-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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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.