Z-0267-2007

AMO PhacoFlex Il Model SI40NB Intraocular Lenses

Name: Z-0267-2007 AMO PhacoFlex Il Model SI40NB Intraocular Lenses
Creator: Advanced Medical Optics, Inc.
Published: 2006-10-31
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2006-10-31 / Terminated

FDA source

Advanced Medical Optics, Inc. began a recall of AMO PhacoFlex Il Model SI40NB Intraocular Lenses on 2006-10-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0267-2007
Status: Terminated
Initiated: 2006-10-31
Posted: 2006-12-14
Terminated: 2012-01-13
Recalling firm: Advanced Medical Optics, Inc.
Product: AMO PhacoFlex Il Model SI40NB Intraocular Lenses
Product code: HQL Intraocular Lens
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.
FDA root cause: Other
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.
Quantity in commerce: 55
Distribution: Nationwide
Product codes and lots: Serial Numbers: 1114110408, 1119570408, 1142040205, 1143100207, 1147320306, 1147330306, 1157290307, 1159120306, 1200580409, 1200700409, 1215800307, 1245260307, 1251300402, 1269240205, 1312400308, 1320420307, 1322770202, 1339940208, 1346040309, 1376660402, 1403090305, 1519560303, 1519570303, 1537150408, 1544970308, 1545920407, 1552190306, 1644880406, 1649280409, 1701830307, 1718970304, 1736210308, 1771500312, 1793030407, 1794700312, 1812750311, 1850350301, 1852450310, 1868930404, 1869430308, 1891830306 & 1897480311. All lenses are clearly identified with a 10 digit serial number. The format of the serial number is described below: Example of serial number format for lens: 1230010212 The first digit denotes the particular manufacturing plant within the AMO facility at Anasco, Puerto Rico, where the product was manufactured. The first digit codes are: - 1 or 2: Silicone Plant - 3: Silicone Rework Plant - 4 or 5: Acrylic Plant - 6: Acrylic Rework Plant Digits two through six denote the sequence of numbers assigned to the lenses. The seven and eighth digit denote the year of manufacture. The ninth and tenth digit denote the month of manufacture. In the serial number example above, the serial number represents the 23001 lens produced in the Silicone plant in December 2002.

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)