Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System 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 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Quantity: 217 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