PMA P980040S184

Device: SENSARTM 1-Piece IOL, AAB00; TECNISTM 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00; TECNISTM 1-Piece OptiB
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S184
Product code: HQL
Decision date: 2026-07-23
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: qualification of a lower holding limit time used during the polyethylene glycol (PEG) surface treatment for Johnson & Johnson Surgical Vision, Inc. (JJSV) One-Piece Intraocular Lenses (IOLs)

Current openFDA PMA Record#

Device: SENSARTM 1-Piece IOL, AAB00; TECNISTM 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00; TECNISTM 1-Piece OptiB
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S184
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-07-23
Decision code: OK30
Date received: 2026-07-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of a lower holding limit time used during the polyethylene glycol (PEG) surface treatment for Johnson & Johnson Surgical Vision, Inc. (JJSV) One-Piece Intraocular Lenses (IOLs)