PMA P980040S066

Device: TECNIS TORIC CALCULATOR
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S066
Product code: HQL
Decision date: 2016-08-16
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval for a software update to your TECNIS® Toric Calculator to include the following:1) Prospective addition of the FDA-approved ZCT375 I0OL); and 2) Incorporation of an optional feature to add the posterior corneal astigmatism (PCA) factor into the toric lens calculation.

Current openFDA PMA Record#

Device: TECNIS TORIC CALCULATOR
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S066
Product code: HQL
Generic name: intraocular lens
Decision date: 2016-08-16
Decision code: APPR
Date received: 2016-01-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software update to your TECNIS® Toric Calculator to include the following:1) Prospective addition of the FDA-approved ZCT375 I0OL); and 2) Incorporation of an optional feature to add the posterior corneal astigmatism (PCA) factor into the toric lens calculation.