Sensar 1-piece IOL recall: Labeling Error
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a…
Why was Sensar 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. 5050941602
- Product
- SENSAR 1-Piece IOL, Model No. AAB00 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
- 1 unit
- 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)