One-Piece IOLs with Daisy-Wheel packaging configuration, One-Piece IOLs with TENIC iTEC Preloaded Delivery System, One-P
FDA premarket approval P980040/S121 · decided 2020-09-23
Approval details
- PMA number
- P980040
- Supplement
- S121
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- One-Piece IOLs with Daisy-Wheel packaging configuration, One-Piece IOLs with TENIC iTEC Preloaded Delivery System, One-P
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-08-25
- Decision date
- 2020-09-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Conducting the flat time test prior to sterilization as opposed to post sterilization as an in-process control for IOLs, within 24 hours of samples being delivered to the flat test area at AMO Puerto Rico site.
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510(k) clearances by this applicant
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|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
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| 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 |