MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
FDA 510(k) clearance K112977 · decided 2012-03-27
Clearance details
- K-number
- K112977
- Device name
- MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
- Applicant
- Alcon Research, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-06
- Decision date
- 2012-03-27
- Days to decision
- 173 days
- Clearance type
- Abbreviated
- Product code
- MSS
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular recall (Z-0978-2017) | Alcon Research, Ltd. | 2017-01-09 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PROVISC Ophthalmic Viscosurgical Device (P890047/S070) | Alcon Research, Ltd. | 2026-08-04 |
| AcrySof ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL (P040020/S120) | Alcon Research, Ltd. | 2026-07-06 |
| AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL (P040020/S119) | Alcon Research, Ltd. | 2026-07-02 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S121) | Alcon Research, Ltd. | 2026-07-02 |
| AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S118) | Alcon Research, Ltd. | 2026-03-02 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117) | Alcon Research, Ltd. | 2025-12-12 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S069) | Alcon Research, Ltd. | 2025-10-03 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116) | Alcon Research, Ltd. | 2025-09-18 |