AMO PhacoFlex Il Model SI40NB Intraocular Lenses
FDA Recall Z-0267-2007 · Posted 2006-12-14
Recalling FirmAdvanced Medical Optics, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2006-10-31
Date Terminated2012-01-13
Product Quantity55
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.
Firm Action
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
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.