Skip to content
Recall Observatory FDA recall evidence

Device 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 cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

Z-2860-2016

August 26, 2016

Class II

Product summary

Firm
Abbott Medical Optics Inc. (AMO)
Event
Event 75051
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2860-2016

Official wording

Reason: 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.

Code information: Serial No. 5050941602

Distribution pattern: Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled