Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk
Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.
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: This FDA Class II recall involves a risk-of-harm device where a molding defect could cause damage to the intraocular lens, though no actual injuries have been reported. The hazard is potential rather than realized.
Plain-English summary
Alcon Research LLC is recalling the Monarch III D Delivery Cartridge (Model 8065977763), a device used to deliver intraocular lenses during cataract surgery.
The recall was initiated due to an increase in complaints of a molding defect within the inner lumen of the delivery cartridge. This defect could result in a scratch on the intraocular lens during delivery.
Approximately 41,718 units have been distributed throughout the United States and internationally to Russia and Egypt.
Patients and healthcare providers should stop using affected cartridges. Contact Alcon Research LLC for instructions regarding device return or replacement.
The recalled product
- Product
- Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 41,718
Distribution
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