Tecnis 1-piece IOL recall: Labeling Error
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a…
Why was Tecnis 1-piece IOL 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. 2005271506 5914601206 4651021512 5807371506 4427981206 4427991206 4428001206 4428011206 4428021206 4428031206 4428041206 4428051206 4428061206 4428071206 4428081206 4428091206 4428101206 4428111206 4428121206 4428131206 4428141206 4428151206 4428161206 4428171206 4428181206 4428191206 4428201206 4428211206 4428221206 4428231206 4428241206 4428251206 4428261206 4428271206 4428281206 4428291206 4428311206 4428321206 4428331206 4428341206 4428351206 4428361206 4428371206 4428381206 5152461501 5152471501 5152481501 5152491501 5152501501 5152531501 5152541501 5152551501 5152561501 5152571501 5152581501 5152591501 5152601501 5152611501 5152621501 5152631501 5152641501 5152651501 5152661501 5152671501 4428301206
- Product
- TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a…
- Recalling firm
- Abbott Medical Optics Inc. (AMO)
- Quantity
- 65 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)