AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
FDA premarket approval P040020/S111 · decided 2025-06-18
Approval details
- PMA number
- P040020
- Supplement
- S111
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2024-12-10
- Decision date
- 2025-06-18
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- approval for a manufacturing site located at [Alcon Huntington West Virginia, 2 Vision Lane, Lesage, West Virginia 25537 for manufacturing processes starting with injection molding and progressing through primary packaging and seal integrity testing.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CENTURION Vision System (Active SentryTM) (K161794) | Alcon Research, Ltd. | 2017-04-14 |
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| CONSTELLATION VISION SYSTEM (K141065) | Alcon Research, Ltd. | 2014-08-22 |
| WAVELIGHT FS200 PATIENT INTERFACE 1505 (K121031) | Alcon Research, Ltd. | 2012-06-21 |
| MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977) | Alcon Research, Ltd. | 2012-03-27 |
| 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951) | Alcon Research, Ltd. | 2011-10-17 |
| CLEARCUT S SAFETY KNIFE (K110166) | Alcon Research, Ltd. | 2011-05-20 |
| ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (K102860) | Alcon Research, Ltd. | 2011-05-10 |