PMA P880081

Device: TECNIS® CL Foldable Silicone IOL
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P880081
Supplement: S047
Product code: HQL
Decision date: 2024-09-27
Generic name: Intraocular Lens
Approval order statement: software improvements made to optical metrology system used for 100 percent in-line inspection of TECNIS 3-Piece Acrylic Monofocal, TECNIS 1-Piece with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal, TECNIS® CL Foldable Silicone, and 5ODEL SI-11NB UV Absorbing Silicone Posterior intraocular lenses

Current openFDA PMA Record#

Device: TECNIS® CL Foldable Silicone IOL
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P880081
Supplement: S048
Decision date: 2024-09-27
Decision code: APPR
Date received: 2023-06-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: software improvements made to optical metrology system used for 100 percent in-line inspection of TECNIS 3-Piece Acrylic Monofocal, TECNIS 1-Piece with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal, TECNIS® CL Foldable Silicone, and 5ODEL SI-11NB UV Absorbing Silicone Posterior intraocular lenses