Alcon Monarch III Cartridge Recalled Due to Potential Lens Lodging
Alcon Research, Ltd. is recalling 1,130 Monarch III (1) "C" Cartridges because the intraocular lens could become lodged within the device.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Alcon Research, Ltd. is recalling 1,130 units of the Alcon Monarch III (1) "C" Cartridge, Model 8065977762, Lot Number 32395407. The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal.
The recall was initiated because the intraocular lens could become lodged within the cartridge. This specific lot was manufactured on August 13, 2015.
The affected units were distributed to Mexico only. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
- Manufacturer
- Alcon Research, Ltd.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 1,130
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Alcon Monarch II C Cartridge Model 8065977762
- Lot Number 32395407
- Manufacture Date 8/13/2015
Distribution
Distribution scope not specified by the agency.
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