PMA P980040S091

Device: TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S091
Product code: HQL
Decision date: 2018-06-11
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Manufacture the TECNIS® Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525 and ZCT600, and the TECNIS® Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, at Johnson & Johnson Surgical Vision, Inc.’s (J&J Vision) AMO Puerto Rico Manufacturing, Inc. facility in Añasco, Puerto Rico.

Current openFDA PMA Record#

Device: TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S091
Product code: HQL
Generic name: intraocular lens
Decision date: 2018-06-11
Decision code: OK30
Date received: 2018-05-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacture the TECNIS® Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525 and ZCT600, and the TECNIS® Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, at Johnson & Johnson Surgical Vision, Inc.’s (J&J Vision) AMO Puerto Rico Manufacturing, Inc. facility in Añasco, Puerto Rico.