Abbott Medical Optics Inc. (AMO): Medical Device Recall in 2016 - (Recall #: Z-2863-2016)

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:

TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. 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-2863-2016

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. 8213991504 8214001504 8214011504 8214021504 8214031504 8214041504 8214051504 8214061504 8214071504 8214101504 8538801603 8538821603 8538831603 8538841603 8538871603 8538891603 8538901603 8538971603 8538981603 8416821507 8416831507 8416841507 8416851507 8416911507 8416921507 8416951507 8416961507 8416971507 8416991507 8417001507 8417011507 8417021507 8417041507 8417071507 8417081507 8417091507 8417101507 8445191507 8505901605 8505911605 8505961605

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