TECNIS TORIC CALCULATOR
FDA premarket approval P980040/S066 · decided 2016-08-16
Approval details
- PMA number
- P980040
- Supplement
- S066
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS TORIC CALCULATOR
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2016-01-28
- Decision date
- 2016-08-16
- Days to decision
- 201 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a software update to your TECNIS® Toric Calculator to include the following:1) Prospective addition of the FDA-approved ZCT375 I0OL); and 2) Incorporation of an optional feature to add the posterior corneal astigmatism (PCA) factor into the toric lens calculation.
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