Recall record at a glance
| Official record | Z-0929-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Abbott Medical Optics Inc (AMO) |
| Report date | Mar 20, 2013 |
| Recall initiation date | Dec 20, 2012 |
| Quantity | 155 units |
| Location | Santa Ana, CA, United States |
Official product description
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Why the product was recalled
Two production orders of these IOLs that contain mislabeled IOLs.
Distribution information
Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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