510(k) K112977 ยท MSS Folders And Injectors, Intraocular Lens (Iol)
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
| Applicant | Alcon Research, Ltd., Fort Worth TX, US |
| Decision | Substantially Equivalent, Mar 27, 2012 |
| Received | Oct 6, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K112977
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2017 | Alcon Research, Ltd. Alcon Monarch III (1) "C" Cartridge
The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal Terminated |
MSS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.