Abbott Medical Optics Inc. (AMO): Medical Device Recall in 2016 - (Recall #: Z-2860-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 26, 2016

Date Posted: September 28, 2016

Recall Number: Z-2860-2016

Event ID: 75051

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.

Status: Terminated

Product Quantity: 1 unit

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.

Voluntary or Mandated:

Voluntary: Firm initiated