PMA P980040S098

Device: Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
Applicant: Johnson & Johnson Surgical Vision, Inc.
Product code: HQL
Decision date: 2019-10-01
Generic name: intraocular lens
Approval order statement: Approval for an additional packaging configuration for TECNIS®, TECNIS® OptiBlue, TECNIS® Multifocal, TECNIS® Toric, TECNIS® Symfony and TECNIS® Symfony Toric one-piece IOLs into the new Simplicity Delivery System.

Current openFDA PMA Record#

Device: Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S098
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-10-01
Decision code: APPR
Date received: 2018-12-21
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an additional packaging configuration for TECNIS®, TECNIS® OptiBlue, TECNIS® Multifocal, TECNIS® Toric, TECNIS® Symfony and TECNIS® Symfony Toric one-piece IOLs into the new Simplicity Delivery System.