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.
Enforcement
- Recall Number
- Z-2857-2016
- Event ID
- 75051
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Medical Optics Inc. (AMO)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 28, 2016
- Initiation Date
- August 26, 2016
- Classification Date
- September 21, 2016
- Termination Date
- December 23, 2016
- Address
- 1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933, United States
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.
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.
Serial No. 8618391605 8618441605 8231911605 8231921605 8231931605 8231961605 8496921508 8496931508 8496941508 8496951508
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
10 units