CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
Tecnis Multifocal 1-Piece Intraocular Lens recalled
Abbott Medical Optics Inc. (AMO) is recalling Tecnis Multifocal 1-Piece Intraocular Lens, distributed nationwide in the US. The recall was initiated on 26 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2856-2016
- FDA event ID
- 75051
- Recalling firm
- Abbott Medical Optics Inc. (AMO), Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Aug 2016
- FDA classified
- 21 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Contact Lenses & Eye Devices
Timeline
| 26 Aug 2016 | Recall initiated by company | |
| 21 Sep 2016 | Classified by FDA | +26 days |
| 28 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Questions about this recall
Why was it 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.
Which lots are affected?
ZKB00 Serial No. 8667461602 8667751602 8667471602 8667761602 8667481602 8667771602 8667491602 8667781602 8667501602 8667801602 8667511602 8667811602 8667521602 8667821602 8667531602 8667831602 8667541602 8667841602 8667551602 8667851602 8667561602 8667861602 8667571602 8667871602 8667581602 8667881602 8667591602 8667891602 8667601602 8667901602 8667611602 8667911602 8667621602 8667921602 8667631602 8667931602 8667641602 8667961602 8667661602 8667971602 8667671602 8667981602 8667681602 8667991602 8667691602 8668001602 8667701602 8668011602 ZLB00 Serial No. 8960421506 8960431506 8960441506 8960451506 8960461506 8960471506 8960481506 8960501506 8960511506 8960531506 8960541506 8960581506 8960591506 8960621506 8960631506 8960641506 8960651506 8960661506 8960671506 8960681506 8960691506 8960701506 8960711506 8960721506 8960731506 8960741506
Where was it sold?
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 75051This product is part of a recall event; the main page for the event is Tecnis OptiBlue 1-Piece Intraocular Lens (IOL) recalled.
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| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |