Abbott Medical Optics Inc. (AMO): Medical Device Recall in 2016 - (Recall #: Z-2857-2016)

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 Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated 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 aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and 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-2857-2016

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: 10 units

Code Information:

Serial No. 8618391605 8618441605 8231911605 8231921605 8231931605 8231961605 8496921508 8496931508 8496941508 8496951508

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