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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Abbott Medical Optics Inc. (AMO)
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2856-2016
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