AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System
FDA premarket approval P930014/S096 · decided 2017-01-13
Approval details
- PMA number
- P930014
- Supplement
- S096
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2016-10-26
- Decision date
- 2017-01-13
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for modifying the physician directions for use to include instructions for removing the IOL from the injector.
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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 |
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