Abbott Recalls TECNIS Symfony Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 10 TECNIS Symfony intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
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, but the source text identifies the hazard as a labeling error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 10 units of the TECNIS Symfony Extended Range of Vision Intraocular Lens (IOL), Model No. ZXR00. The recall was initiated because the lenses were not being checked prior to release, which may result in the release of mislabeled IOLs.
The affected product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. The lenses are intended to be placed in the capsular bag after cataract extraction or refractive lensectomy. The specific serial numbers involved in this recall are 8618391605, 8618441605, 8231911605, 8231921605, 8231931605, 8231961605, 8496921508, 8496931508, 8496941508, and 8496951508.
The product was distributed worldwide, including the US nationwide, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific. Patients who have had these specific lenses implanted should contact their eye care provider to verify the serial number of their implanted lens and discuss any concerns regarding the labeling issue.
The recalled product
- Product
- TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and…
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Abbott Medical Optics Inc. (AMO) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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