PMA P980040S146

Device: TECNIS IOLs
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S146
Product code: HQL
Decision date: 2022-03-30
Generic name: intraocular lens
Approval order statement: Expansion of feed rate, tumbling, high-resolution technology and 100-percent in-line image quality measurement system to 3 existing production lines at AMO Puerto Rico facility for manufacturing TECNIS Symfony and TECNIS Symfony Toric II Optiblue Extended Range of Vision Intraocular Lenses (IOL) as well as TECNIS Synergy and TECNIS Synergy Toric II lOLs with TECNIS Simplicity Delivery System.

Current openFDA PMA Record#

Device: TECNIS IOLs
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S146
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-03-30
Decision code: OK30
Date received: 2022-03-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Expansion of feed rate, tumbling, high-resolution technology and 100-percent in-line image quality measurement system to 3 existing production lines at AMO Puerto Rico facility for manufacturing TECNIS Symfony and TECNIS Symfony Toric II Optiblue Extended Range of Vision Intraocular Lenses (IOL) as well as TECNIS Synergy and TECNIS Synergy Toric II lOLs with TECNIS Simplicity Delivery System.