Recall Z-0267-2007 ยท HQL Intraocular Lens
Advanced Medical Optics, Inc.
AMO PhacoFlex Il Model SI40NB Intraocular Lenses
| Date | Dec 14, 2006 (initiated Oct 31, 2006) |
| Status | Terminated |
| Reason | These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping. |
| Root cause | Other |
| Action | On October 31, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses. AMO will provide updates to the FDA, including all information regarding the recall effe |
| Quantity | 55 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.