FDA-Device2016-09-28Class II
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
Abbott Medical Optics Inc. (AMO)
Hazard
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.
Sold states
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Affected count
10 units
Manufactured in
1700 E Saint Andrew Pl, Santa Ana, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2857-2016Don't want to check this manually?
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