FDA Device recall Z-0929-2013
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posteri…
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posteri… by Abbott Medical Optics Amo, citing two production orders of these IOLs that contain mislabeled IOLs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0929-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-20 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Medical Optics Amo |
| Distribution | US |
Product
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.
Reason
Two production orders of these IOLs that contain mislabeled IOLs.
Identifiers
| code_info | Diopter 18.0 4760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207…Diopter 18.0 4760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207 4761221207 4760301207 4760721207 4761231207 4760311207 4760741207 4761241207 4760321207 4760761207 4761251207 4760331207 4760781207 4761261207 4760341207 4760801207 4761271207 4760351207 4760811207 4761281207 4760361207 4760821207 4760371207 4760841207 4760381207 4760861207 4760391207 4760881207 4760401207 4760901207 4760411207 4760921207 4760421207 4760941207 4760431207 4760961207 4760441207 4760981207 4760451207 4761001207 4760461207 4761031207 4760471207 4761041207 4760481207 4761051207 4760491207 4761061207 4760501207 4761071207 4760511207 4761081207 4760531207 4761091207 4760551207 4761101207 4760571207 4761111207 4760591207 4761121207 4760601207 4761131207 4760611207 4761151207 4760621207 4761161207 4760631207 4761171207 47 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0929-2013%22
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