AcrySof IQ Tonic Lenses
FDA premarket approval P930014/S103 · decided 2017-09-21
Approval details
- PMA number
- P930014
- Supplement
- S103
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AcrySof IQ Tonic Lenses
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2017-06-06
- Decision date
- 2017-09-21
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the use of the Enhanced Dry NIMO Wavefront Measurement System for quality control inspection of optical performance for in situ spherical equivalent and cylindrical powers, image quality, spherical aberration and labeled axis of AcrySof® Toric Intraocular Lenses (IOLs), and spherical aberration and labeled axis of AcrySof® Multifocal and Multifocal-Toric Intraocular Lenses.
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510(k) clearances by this applicant
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| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |