AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses

FDA device recall Z-0148-2007 · posted 2006-12-14 · Terminated

Recall details

Recalling firm

Advanced Medical Optics, Inc.

Reason for recall

The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.

Action taken

On November 13, 2006, an 'URGENT MEDICAL DEVICE RECALL' letter was mailed to all affected US customers communicating their recall strategy regarding the removal of five (5) ZA9003 lenses in US distribution. This letter included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses.

Root cause

Other

Status

Terminated

Product code

HQL

Quantity affected

10 lenses

Distribution

Worldwide, including USA (CT, TX, NY), Canada, and UK.

Date initiated

2006-11-29

Date posted

2006-12-14

Date terminated

2011-05-24

Location

Santa Ana, CA