BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens— 510(k) K143280

Substantially Equivalent

Brien Holden Vision Pty , Ltd.

FDA 510(k) clearance K143280 for BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens, Substantially Equivalent on 2015-04-23. Applicant: Brien Holden Vision Pty , Ltd..

Clearance details

Applicant: Brien Holden Vision Pty , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2014-11-14
Decision date: 2015-04-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sydney, AU

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.