Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following ca
FDA device recall Z-0978-2017 · posted 2017-01-09 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- The intraocular lens could become lodged within the cartridge
- Action taken
- 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 817-551-3058.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MSS
- Quantity affected
- 1,130 units
- Distribution
- Distributed to Mexico only
- Date initiated
- 2016-09-05
- Date posted
- 2017-01-09
- Date terminated
- 2017-02-10
- Location
- Fort Worth, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977) | Alcon Research, Ltd. | 2012-03-27 |