PMA P980040S161

Device: TECNIS Symfony™ Extended Range Of Vision Intraocular Lens
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S161
Product code: POE
Decision date: 2023-12-22
Classification: Ophthalmic
Generic name: Extended depth of focus intraocular lens
Approval order statement: approval of modifications to the final professional and patient labeling for the TECNIS Symfony™ Extended Range Of Vision Intraocular Lens (Models ZXR00 and ZXT 150-600) to include the results of your postmarket study.

Current openFDA PMA Record#

Device: TECNIS Symfony™ Extended Range Of Vision Intraocular Lens
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S161
Product code: POE
Generic name: Extended depth of focus intraocular lens
Decision date: 2023-12-22
Decision code: APPR
Date received: 2023-07-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval of modifications to the final professional and patient labeling for the TECNIS Symfony™ Extended Range Of Vision Intraocular Lens (Models ZXR00 and ZXT 150-600) to include the results of your postmarket study.