AMO PhacoFlex Il Model SI40NB Intraocular Lenses

FDA device recall Z-0267-2007 · posted 2006-12-14 · Terminated

Recall details

Recalling firm

Advanced Medical Optics, Inc.

Reason for recall

These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.

Action taken

On October 31, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). 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. AMO will provide updates to the FDA, including all information regarding the recall effectiveness and test results obtained as part of our continuing investigation, as part of the recall progress reports.

Root cause

Other

Status

Terminated

Product code

HQL

Quantity affected

55

Distribution

Nationwide

Date initiated

2006-10-31

Date posted

2006-12-14

Date terminated

2012-01-13

Location

Santa Ana, CA