ACRYSOF SINGLE-PIECE INTRAOCULAR LENSES (IOL)
FDA premarket approval P930014/S028 · decided 2008-10-15
Approval details
- PMA number
- P930014
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACRYSOF SINGLE-PIECE INTRAOCULAR LENSES (IOL)
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2008-09-23
- Decision date
- 2008-10-15
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- MOVING OF THE IOL FINAL PACKAGING AND SECONDARY LABELING OPERATIONS, WITH THREE (3) SUPPORT FUNCTIONS, INTO THE RECENTLY CONSTRUCTED NEW FACILITY ON THE SAME PROPERTY.
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510(k) clearances by this applicant
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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 |