Recall Z-2862-2016— 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 OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. 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 OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. 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.