Alcon Recalls AcrySof IQ Intraocular Lenses Due to Incorrect Diopter
Alcon Research LLC is recalling 84 units of AcrySof IQ intraocular lenses because they have an incorrect diopter. The lenses were distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is an incorrect diopter, which is a labeling/specification error that may result in suboptimal vision but does not typically cause immediate serious injury or death, fitting the Moderate severity criteria for minor labeling or specification errors.
Plain-English summary
Alcon Research LLC is recalling 84 units of AcrySof IQ Intraocular Lenses (IOLs) with the UltraSert System. The recall is being conducted because the lenses have an incorrect diopter. The specific product is the AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER, with a 13.0mm length and 6.0mm anterior asymmetric biconvex optic.
The affected units are identified by Lot number 12726594 and Model Number AU00T0V205. The recall number is Z-2287-2020. The product was distributed nationwide, including in the states of Texas, Pennsylvania, Connecticut, Iowa, Michigan, and Nebraska.
Consumers and healthcare providers should check their inventory for this specific lot and model number. If the product is found, it should be removed from use and returned to Alcon Research LLC or the distributor. Patients who have already had these lenses implanted should contact their eye care provider for guidance.
The recalled product
- Product
- Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
- Manufacturer
- Alcon Research LLC
- Affected units
- 84
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 (4)
- Lot number 12726594
- Model Number: AU00T0V205
- UDI # 038065GMN000065H7
- 0380652394772(17)220630(21)12726594000(30)1
Distribution
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