FDA Medical Device Recalls (openFDA)
Advanced Medical Optics, Inc.: AMO PhacoFlex Il Model SI40NB Intraocular Lenses
- Recall number
- Z-0267-2007
- Recalling firm
- Advanced Medical Optics, Inc.
- Product
- AMO PhacoFlex Il Model SI40NB Intraocular Lenses
- Status
- Terminated
- Initiated
- 2006-10-31
- Posted
- 2006-12-14
- Terminated
- 2012-01-13
- Reason
- 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.
- 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
- 55
- Distribution
- Nationwide
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P880081"]
- Product code
- HQL
- Firm FEI
- 3003843509
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28