CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report
Alcon Monarch III "C" Cartridge The device is used recalled
Alcon Research is recalling Alcon Monarch III "C" Cartridge The device is used for implanting AcrySof intraocular. The recall was initiated on 5 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0978-2017
- FDA event ID
- 75049
- Recalling firm
- Alcon Research, Fort Worth, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2016
- FDA classified
- 9 Jan 2017
- Reported
- 18 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 5 Sep 2016 | Recall initiated by company | |
| 9 Jan 2017 | Classified by FDA | +126 days |
| 18 Jan 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The intraocular lens could become lodged within the cartridge
Product as listed by the FDA
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
Where it was distributed
Distributed to Mexico only
Questions about this recall
Why was it recalled?
The intraocular lens could become lodged within the cartridge
Which lots are affected?
Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015
Where was it sold?
Distributed to Mexico only
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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