Recall Z-0929-2013 ยท HQL Intraocular Lens
Abbott Medical Optics Inc (AMO)
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.
| Date | Mar 9, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | Two production orders of these IOLs that contain mislabeled IOLs. |
| Root cause | Process control |
| Action | AMO sent an Urgent Field Safety Notice letter to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to stop using and remove affected product from inventory. The letter advice customers to complete and return the enclosed Facsimile Form. For questions contact AMO Customer Service Representative. |
| Quantity | 155 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.