Recall Z-2857-2016— Abbott Medical Optics Inc. (AMO)
Class II · Terminated
Class II FDA medical device recall by Abbott Medical Optics Inc. (AMO), initiated 2016-08-26, terminated 2016-12-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Abbott Medical Optics Inc. (AMO)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-26
- Terminated
- 2016-12-23
- Firm location
- Santa Ana, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.