FDA Medical Device Recalls (openFDA)
Advanced Medical Optics, Inc.: AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
- Recall number
- Z-0148-2007
- Recalling firm
- Advanced Medical Optics, Inc.
- Product
- AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
- Status
- Terminated
- Initiated
- 2006-11-29
- Posted
- 2006-12-14
- Terminated
- 2011-05-24
- Reason
- The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
- Root cause
- Other
- Action
- 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.
- Quantity
- 10 lenses
- Distribution
- Worldwide, including USA (CT, TX, NY), Canada, and UK.
- Lot, serial or model codes
- Serial numbers: 531644065, 5316450605, 5316460605, 5316470605, 5316490605, 5316500605, and 5316510605
- 510(k) numbers
- not on file
- PMA numbers
- ["P990080/S6"]
- 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