Recall Z-0978-2017 ยท MSS Folders And Injectors, Intraocular Lens (Iol)
Alcon Research, Ltd.
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
| Date | Jan 9, 2017 (initiated Sep 5, 2016) |
| Status | Terminated |
| Reason | The intraocular lens could become lodged within the cartridge |
| Root cause | Device Design |
| Action | Alcon sent an Urgent Field Safety Action letter dated August 2016 to all affected consignees who received the affected product. Customers were instructed to check their inventory and segregate any of the affected cartridges. Customers were also asked to complete and return the Product Recall Response Form. , requesting the return of any units in their inventory. If customers had transferred product to other organizations, they were asked to provide them with a copy of the notice. Customers with questions were instructed to contact Alcon. For questions regarding this recall call 817-551-30 |
| Quantity | 1,130 units |
| Distribution | Distributed to Mexico only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) Alcon Research, Ltd., Mar 27, 2012 |