ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS
FDA premarket approval P930014/S012 · decided 2003-09-02
Approval details
- PMA number
- P930014
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2003-08-05
- Decision date
- 2003-09-02
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL TO MODIFY THE PACKAGE INSERT TO CREATE A NEW WARNING BY MOVING AND STRENGTHENING EXISTING TEXT WITHIN THE APPROVED INSERT TO READ AS FOLLOWS: "THE CLINICAL STUDY OF THE ACRYSOF NATURAL SINGLE-PIECE LENS (REFERENCED IN TABLES 2 THROUGH 5) WAS CONDUCTED WITH THE LENS INTENDED FOR IMPLANTATION IN THE CAPSULAR BAG ONLY. THERE IS NO CLINICAL DATA TO DEMONSTRATE ITS SAFETY AND EFFECTIVENESS FOR PLACEMENT IN THE CILIARY SULCUS."
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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 |