Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TECNIS Multifocal 1-Piece Intraocular Lens Recalled by Abbott Medical Optics Inc. (AMO) Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Medical Optics Inc. (AMO) directly.
Affected Products
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for 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 who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
Quantity: 77 units
Why Was This Recalled?
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Medical Optics Inc. (AMO)
Abbott Medical Optics Inc. (AMO) has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report