PMA P980040S177

Device: TECNIS™ Toric II 1-Piece IOLs, ZCU TECNIS Symfony Toric II Extended Range of Vision IOLs, ZXU TECNIS Eyhance Toric II IO
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S177
Product code: HQL
Decision date: 2025-09-02
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: a modification of the sampling size for two in-process identification tests

Current openFDA PMA Record#

Device: TECNIS™ Toric II 1-Piece IOLs, ZCU TECNIS Symfony Toric II Extended Range of Vision IOLs, ZXU TECNIS Eyhance Toric II IO
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S177
Product code: HQL
Generic name: intraocular lens
Decision date: 2025-09-02
Decision code: OK30
Date received: 2025-08-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a modification of the sampling size for two in-process identification tests