TECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM
FDA premarket approval P980040/S068 · decided 2016-05-13
Approval details
- PMA number
- P980040
- Supplement
- S068
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2016-04-18
- Decision date
- 2016-05-13
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of an alternate molding supplier for the lower and upper body components used in all TECNIS iTec Preloaded Delivery System lens models manufactured at the AMO Puerto Rico and AMO Groningen BV sites.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 |