Food, drugs, devices › Alcon Research, Ltd.
Device recall: Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following ca
Alcon Research, Ltd. (Fort Worth, TX) initiated this device recall on 5 Sep 2016; FDA lists 1 product record under event 75049, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 10 Feb 2017. Initiation: voluntary: firm initiated. Alcon Research, Ltd. has 28 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alcon Research, Ltd., Fort Worth, TX.
Reason for recall
"The intraocular lens could become lodged within the cartridge"
Distribution
"Distributed to Mexico only"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0978-2017 | Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal | 1,130 units | Class II | Terminated | 18 Jan 2017 |
Context
Other enforcement events for Alcon Research, Ltd.
All 28 events for Alcon Research, Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The intraocular lens could become lodged within the cartridge"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to Mexico only"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Feb 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.