VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)— 510(k) K062614

Substantially Equivalent

Johnson & Johnson Vision Care, Inc.

FDA 510(k) clearance K062614 for VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY), Substantially Equivalent on 2006-11-01. Applicant: Johnson & Johnson Vision Care, Inc..

Clearance details

Applicant: Johnson & Johnson Vision Care, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2006-09-05
Decision date: 2006-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Jacksonville, FL, US

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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.