Recall Z-1123-2014 ยท HQL Intraocular Lens
AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
| Date | Mar 3, 2014 (initiated Jan 28, 2014) |
| Status | Terminated |
| Reason | Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. |
| Root cause | Nonconforming Material/Component |
| Action | Beginning on January 28, 2014, AMO began distribution of the Recall Notification Letter to the 72 AMO TECNIS IOL customer accounts within the United States who had received lenses from the 2 affected P/O's. 100% delivery of the recall communication to US customers was confirmed on January 31, 2014. Included with the Recall Notification Letter is a facsimile delivery confirmation which each customer is instructed to fax back to AMO. |
| Quantity | 169 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.