510(k) K010114— ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)

Substantially Equivalent

Johnson & Johnson Vision Care, Inc.

Clearance details

Applicant: Johnson & Johnson Vision Care, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-01-16
Decision date: 2001-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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.