Tecnis 3-Piece Multifocal IOL
FDA premarket approval P080010/S014 · decided 2017-10-27
Approval details
- PMA number
- P080010
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tecnis 3-Piece Multifocal IOL
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2017-09-28
- Decision date
- 2017-10-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Change to the acceptance criteria and inspection test method for the intraocular lens material.
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