SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS— 510(k) K061157

Substantially Equivalent

Bausch & Lomb

FDA 510(k) clearance K061157 for SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS, Substantially Equivalent on 2006-06-22. Applicant: Bausch & Lomb.

Clearance details

Applicant: Bausch & Lomb
Product code: Code MVN
Advisory panel: Ophthalmic
Date received: 2006-04-26
Decision date: 2006-06-22
Decision: Substantially Equivalent
Clearance type: Special
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.