TECNIS Multifocal Foldable Acrylic Intraocular Lens recall: Labeling Error
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of…
Why was TECNIS Multifocal Foldable Acrylic Intraocular Lens 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial No. 8213991504 8214001504 8214011504 8214021504 8214031504 8214041504 8214051504 8214061504 8214071504 8214101504 8538801603 8538821603 8538831603 8538841603 8538871603 8538891603 8538901603 8538971603 8538981603 8416821507 8416831507 8416841507 8416851507 8416911507 8416921507 8416951507 8416961507 8416971507 8416991507 8417001507 8417011507 8417021507 8417041507 8417071507 8417081507 8417091507 8417101507 8445191507 8505901605 8505911605 8505961605
- Product
- TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of…
- Recalling firm
- Abbott Medical Optics Inc. (AMO)
- Quantity
- 41 units
- Distribution
- Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
- Recall date
- September 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)