ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS
FDA premarket approval P040020/S049 · decided 2016-12-22
Approval details
- PMA number
- P040020
- Supplement
- S049
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2013-08-09
- Decision date
- 2016-12-22
- Days to decision
- 1231 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the AcrySof IQ ReSTOR +3.0 D Multifocal Toric Intraocular Lens. This device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder and increased spectacle independence. The lens is intended to be placed in the capsular bag.
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510(k) clearances by this applicant
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|---|---|---|
| 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 |