VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR— 510(k) K991163

Substantially Equivalent

Vistakon, Johnson & Johnson Vision Products, Inc.

FDA 510(k) clearance K991163 for VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR, Substantially Equivalent on 1999-06-08. Applicant: Vistakon, Johnson & Johnson Vision Products, Inc..

Clearance details

Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1999-04-07
Decision date: 1999-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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.