Abbott Recalls TECNIS Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 217 TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
What this means for you
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 labeling error (mislabeled IOLs) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 217 units of the TECNIS 1-Piece Intraocular Lens (IOL) with the TECNIS iTec Preloaded Delivery System, Model No. PCB00. 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 products are 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 lenses are intended to be placed in the capsular bag. The recall covers units 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 professional for guidance. The specific serial numbers affected are listed in the official FDA recall record Z-2861-2016.
The recalled product
- Product
- 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 inten
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 217
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 Pro Due to Possible 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 →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02