Reported Sep 28, 2016 · Terminated
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation…
Abbott Medical Optics Inc. (AMO)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical Optics Inc. (AMO) · 1700 E Saint Andrew Pl · Santa Ana, CA · 92705-4933
Is this the product you have?
- TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for 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 who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
- Lot codes and dates
- ZKB00 Serial No.Serial No.
866746160286677516028667471602866776160286674816028667771602866749160286677816028667501602866780160286675116028667811602866752160286678216028667531602866783160286675416028667841602866755160286678516028667561602866786160286675716028667871602866758160286678816028667591602866789160286676016028667901602866761160286679116028667621602866792160286676316028667931602866764160286679616028667661602866797160286676716028667981602866768160286679916028667691602866800160286677016028668011602ZLB00
89604215068960431506896044150689604515068960461506896047150689604815068960501506896051150689605315068960541506896058150689605915068960621506896063150689606415068960651506896066150689606715068960681506896069150689607015068960711506896072150689607315068960741506
- ZKB00 Serial No.
- Amount recalled
- 77 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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