DeviceClearance

Product code MVN— Ophthalmic

ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR

Classification name
Lens, Contact, (Disposable)
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Total cleared
26
First cleared
Most recent

Market context for product code MVN

FDA has cleared 26 devices under product code MVN between 1999 and 2026, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MVN

Adverse events under product code MVN

product code MVN
Injury
149
Total
149

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MVN

Data sourced from openFDA. This site is unofficial and independent of the FDA.