PMA P990080S067

Device: TECNIS Foldable Acrylic IOL with OptiEdge, Model ZA9003
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P990080
Supplement: S067
Product code: HQL
Decision date: 2026-10-19
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: the transfer of microbiology testing from an external contractor to an in-house laboratory to support product manufacturing at the AMO Puerto Rico manufacturing site

Current openFDA PMA Record#

Device: TECNIS Foldable Acrylic IOL with OptiEdge, Model ZA9003
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P990080
Supplement: S067
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-10-19
Decision code: OK30
Date received: 2026-09-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the transfer of microbiology testing from an external contractor to an in-house laboratory to support product manufacturing at the AMO Puerto Rico manufacturing site