Abbott Recalls 41 Intraocular Lenses Due to Mislabeled Product Risk
Abbott Medical Optics is recalling 41 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, posing a risk of mislabeling.
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 and involves a risk of mislabeling without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 41 units of the TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00. The recall was initiated because the lenses were not being checked prior to release, which may result in the release of mislabeled products.
The affected lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. The distribution pattern for these units is worldwide, including the US nationwide, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific.
Consumers and healthcare providers should check their inventory for the specific serial numbers listed in the official recall notice. If a patient has received one of these lenses, they should contact their eye care provider for further instructions.
The recalled product
- Product
- TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 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…
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 41
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.
See all 10 products in this recall →Related recalls
Same manufacturer · Abbott Medical Optics Inc. (AMO)
See all →- LowAbbott AMO Vitrectomy Cutters Recalled for Packaging Error
FDA (Devices) · 2017-05-24
- HighAbbott Recalls Healon Duet Due to Potential Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon Medical Device Due to Glass Particle Risk
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon GV Due to Possible Microscopic Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon 5 Pro Due to Possible Glass Particles
FDA (Devices) · 2017-05-17
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateAbbott TECNIS Intraocular Lenses Recalled for Expiration Date Violations
FDA (Devices) · 2018-11-21
- ModerateAbbott Recalls Mislabeled AMO Sensar Intraocular Lenses
FDA (Devices) · 2013-03-20
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAaren Scientific Recalls Intraocular Lenses Due to Non-Compliant Instructions
FDA (Devices) · 2015-04-01