PMA P980040S079

Device: TECNIS Toric 1-Piece IOL Model ZCT
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S079
Product code: MJP
Decision date: 2017-03-24
Classification: Lens, Intraocular, Toric Optics
Generic name: LENS, INTRAOCULAR, TORIC OPTICS
Approval order statement: Addition of the AMO Kulim, Malaysia manufacturing site for the production of your TECNIS Toric IOL Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525, and ZCT600.

Current openFDA PMA Record#

Device: TECNIS Toric 1-Piece IOL Model ZCT
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S079
Product code: MJP
Generic name: LENS, INTRAOCULAR, TORIC OPTICS
Decision date: 2017-03-24
Decision code: OK30
Date received: 2017-02-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of the AMO Kulim, Malaysia manufacturing site for the production of your TECNIS Toric IOL Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525, and ZCT600.