Recall Z-0929-2013— Abbott Medical Optics Inc (AMO)
Class II · Terminated
Class II FDA medical device recall by Abbott Medical Optics Inc (AMO), initiated 2012-12-20, terminated 2014-01-08. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Abbott Medical Optics Inc (AMO)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-20
- Terminated
- 2014-01-08
- Firm location
- Santa Ana, CA, United States
Product description
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 for recall
Two production orders of these IOLs that contain mislabeled IOLs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.