PMA P980040S148

Device: TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S148
Product code: HQL
Decision date: 2022-07-20
Generic name: intraocular lens
Approval order statement: Adoption of additional intraocular lens models and packaging configurations into the existing approved sterilization process, SPS100, using sterilization vessel #8 and hot cell #5, at AMO Puerto Rico site.

Current openFDA PMA Record#

Device: TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S148
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-07-20
Decision code: OK30
Date received: 2022-06-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Adoption of additional intraocular lens models and packaging configurations into the existing approved sterilization process, SPS100, using sterilization vessel #8 and hot cell #5, at AMO Puerto Rico site.