Abbott Medical Optics Inc. (AMO)
Complete recall history across all FDA and CPSC categories — 17 total recalls
Abbott Medical Optics Inc. (AMO) appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (17)
FDA medical device enforcement actions by Abbott Medical Optics Inc. (AMO)
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 1, 2017 | Healon V, Part No. 10290045 | Remote possibility that certain solutions in these lots may contain microscop... | Class II |
| Apr 1, 2017 | Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 | Remote possibility that certain solutions in these lots may contain microscop... | Class II |
| Apr 1, 2017 | Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, ... | Remote possibility that certain solutions in these lots may contain microscop... | Class II |
| Apr 1, 2017 | Healon 5 Pro, Part No. 10270015 | Remote possibility that certain solutions in these lots may contain microscop... | Class II |
| Apr 1, 2017 | Healon Pro, Part No. 10270012 | Remote possibility that certain solutions in these lots may contain microscop... | Class II |
| Apr 1, 2017 | Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 | Remote possibility that certain solutions in these lots may contain microscop... | Class II |
| Mar 30, 2017 | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... | Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and... | Class II |
| Aug 26, 2016 | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 Th... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The pro... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantatio... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The pro... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantatio... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is ind... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
| Aug 26, 2016 | TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they wer... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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