Abbott Medical Optics Inc. (AMO): Medical Device Recall in 2016 - (Recall #: Z-2864-2016)

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:

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 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-2864-2016

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: 41 units

Code Information:

Serial No. 1104621505 1164491602 1164501602 1164511602 1164521602 1164541602 1164551602 1164561602 1164571602 1164581602 1164601602 1164611602 1164621602 1164641602 1164651602 1164711602 1074911602 1074921602 1074931602 1074941602 1074951602 1074961602 1074971602 1074981602 1074991602 1075001602 1075011602 1075021602 1075031602 1075041602 1075051602 1075061602 1075071602 1075081602 1075091602 1075101602 1075111602 1075131602 1075141602 1075151602 1075121602

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