Abbott Medical Optics Inc. (AMO): Medical Device Recall in 2016 - (Recall #: Z-2862-2016)

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 OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V 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-2862-2016

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: 70 units

Code Information:

Serial No. 5860621403 5860631403 5860641403 5860651403 5860661403 5860671403 5860681403 5860691403 5860701403 5860711403 5860721403 5860731403 5860741403 5860751403 5860771403 5860781403 5860791403 5860801403 5860811403 5860821403 5860831403 5860851403 5860871403 5860881403 5860891403 5860901403 5860911403 5860921403 5860931403 5860941403 5860951403 5860961403 5860971403 5860981403 5860991403 5861001403 5861011403 5861021403 5861031403 5861041403 5861051403 5861061403 5861081403 5861091403 5861101403 5861111403 5861391403 5861401403 5861411403 5861421403 5861431403 5861441403 5861451403 5861461403 5861471403 5861481403 5861491403 5861501403 5861511403 5861521403 5861531403 5861541403 5861551403 5861561403 5861581403 5861591403 5861601403 5861611403 5861621403 5861631403

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