VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control— 510(k) K203060

Substantially Equivalent

Johnson & Johnson Surgical Vision, Inc.

FDA 510(k) clearance K203060 for VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control, Substantially Equivalent on 2021-03-12. Applicant: Johnson & Johnson Surgical Vision, Inc..

Clearance details

Applicant
Johnson & Johnson Surgical Vision, Inc.
Product code
Code HQC
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Ana, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HQC

product code HQC
Injury
2,378
Malfunction
8,768
Total
11,146

Source: openFDA MAUDE database, through . 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.