AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL (SA60WF); AcrySof
FDA premarket approval P930014/S161 · decided 2026-04-30
Approval details
- PMA number
- P930014
- Supplement
- S161
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL (SA60WF); AcrySof
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2026-01-30
- Decision date
- 2026-04-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- approval application (PMA) 180-day supplement, which requested approval for a new packaging configuration, automation of the primary and secondary packaging processes, and updates to shelf-life and storage conditions of the AcrySof IOLs (storage condition temperatures from 45 °C to 30 °C), and Clareon IOLs (to extend the shelf life from four (4) years to five (5) years at the temperature of 30 °C) in Alcons manufacturing facilities in West Virginia, USA and Cork, Ireland.
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510(k) clearances by this applicant
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|---|---|---|
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| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
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| 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 |