Monarch® III
The Monarch® "D" Cartridge is a single-use polypropylene cartridge for posterior chamber IOL delivery
1manufacturer
2catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | KYB |
| Device type | Lens, Guide, Intraocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4300 |
| Premarket notification | Exempt |
| Record published | 2020-08-19 |
| Record revised | 2022-12-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065977773 | In distribution | |
| 8065977763 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Duckworth & Kent | Duckworth AND Kent Limited | 5 |
| Unfolder Emerald | Johnson & Johnson Surgical Vision, Inc. | 3 |
| Monarch® II | Alcon Laboratories, Inc. | 2 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 2 |
| Unfolder Silver | Johnson & Johnson Surgical Vision, Inc. | 2 |
| IOL Manipulator – Sinskey | Hurricane Medical | 2 |
| Lens Exchange Sytem | Visioncare Ophthalmic Technologies Ltd. | 2 |
| Viscoject 1.8 Injector Set | Medicel AG | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Nucleus Chopper – P. Koch | Hurricane Medical | 1 |
| Surgical Glide | Hurricane Medical | 1 |
| Unfolder Platinum 1 Series | Johnson & Johnson Surgical Vision, Inc. | 1 |
Showing 12 of 18. All products under Lens, Guide, Intraocular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K981571 | 1998-07-09 |
| K970033 | 1997-04-23 |
| K965185 | 1997-03-31 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Alcon Research, LLC | UDI-DI | 2024-11-13 | Class II | Process design | Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery. | 41718 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.