Z-2857-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2016
- Initiation Date
- August 26, 2016
- Termination Date
- December 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.
Reason for Recall
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Distribution Pattern
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Code Information
Serial No. 8618391605 8618441605 8231911605 8231921605 8231931605 8231961605 8496921508 8496931508 8496941508 8496951508