Recall Z-0148-2007 ยท HQL Intraocular Lens
Advanced Medical Optics, Inc.
AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
| Date | Dec 14, 2006 (initiated Nov 29, 2006) |
| Status | Terminated |
| Reason | The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters. |
| Root cause | Other |
| Action | On November 13, 2006, an 'URGENT MEDICAL DEVICE RECALL' letter was mailed to all affected US customers communicating their recall strategy regarding the removal of five (5) ZA9003 lenses in US distribution. This letter 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. |
| Quantity | 10 lenses |
| Distribution | Worldwide, including USA (CT, TX, NY), Canada, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.