CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS— 510(k) K033919

Substantially Equivalent

Ciba Vision Corporation

FDA 510(k) clearance K033919 for CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS, Substantially Equivalent on 2004-03-12. Applicant: Ciba Vision Corporation.

Clearance details

Applicant: Ciba Vision Corporation
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2003-12-18
Decision date: 2004-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duluth, GA, 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.