Alcon Clareon IOL mislabeled due to manufacturing error
Alcon is recalling specific lots of Clareon intraocular lenses (IOLs) due to mislabeling caused by improper manufacturing line clearance. The mislabeling resulted from partial product mixing during overlapping manufacturing runs.
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: FDA Class II medical device recall with mislabeling as the identified hazard. No illnesses, injuries, or adverse events are reported. This meets the High (3) criterion for risk-of-harm products without reported injury.
Plain-English summary
Alcon Laboratories Ireland, Ltd. is recalling specific lots of Clareon IOL (intraocular lens) with AutonoMe Delivery System devices. The affected devices are mislabeled. The mislabeling was caused by partial mixing of product that occurred during overlapping manufacturing runs due to improper manufacturing line clearance.
Two lots are affected: Lot 25238769 (139 lenses, Catalog Number CNA0T0.175) and Lot 25238775 (164 lenses, Catalog Number CNA0T0.240). These devices were distributed in 16 U.S. states (Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Michigan, Missouri, New York, Ohio, Oklahoma, Texas, Virginia, and Wisconsin) and internationally to the Czech Republic, France, Germany, India, Slovakia, Spain, and Switzerland.
The FDA classified this as a Class II recall. The recalling firm initiated the recall.
The recalled product
- Product
- Alcon Clareon IOL with AutonoMe Delivery System
- Manufacturer
- Alcon Laboratories Ireland, Ltd
- Hazard
Distribution
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