ACRYSOF INTRAOCULAR LENS
FDA premarket approval P930014/S087 · decided 2015-12-31
Approval details
- PMA number
- P930014
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACRYSOF INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2015-12-07
- Decision date
- 2015-12-31
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- ALCON LABORATORIES IRELAND LTD. AS AN ALTERNATE INTRAOCULAR LENS MANUFACTURING FACILITY FOR ACRYSOF IQ TORIC IOL (MODELS SN6AT6, SN6AT7, SN6AT8, SN6AT9) AND THE USE OF THE MANUAL WET NIMO EQUIPMENT FOR THE SPHERICAL ABERRATION MEASUREMENT MANUFACTURING PROCESS STEP IN PLACE OF THE CURRENT LONG WET MANUAL ABERROMETER SYSTEM SPECIFICALLY FOR LOW DIOPTER (6.0 ¿ 9.5 DIOPTER) IQ TORIC LENSES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052) | Alcon Laboratories, Inc. | 2026-02-13 |
| LenSx Laser System (8065000944) (K252682) | Alcon Laboratories, Inc. | 2025-09-24 |
| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
| Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (K243909) | Alcon Laboratories, Inc. | 2025-01-13 |
| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| 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 |