FDA Medical Device Recalls (openFDA)
Advanced Medical Optics, Inc.: CeeOn Heparin Surface Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU)
- Recall number
- Z-0096-06
- Recalling firm
- Advanced Medical Optics, Inc.
- Product
- CeeOn Heparin Surface Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU)
- Status
- Terminated
- Initiated
- 2005-10-05
- Posted
- 2005-10-28
- Terminated
- 2008-05-23
- Reason
- A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
- Root cause
- Other
- Action
- A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
- Quantity
- 45 (4 in US)
- Distribution
- Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam
- Lot, serial or model codes
- CeeOn¿ One-Piece PMMA 722C, 10 lenses PMMA HSM 722C +19,5 8094420508 8094430508 8094440508 PMMA HSM 722C +22,5 8032640508 8032830508 8032840508 8032850508 PMMA HSM 722C +23,0 8266000508 PMMA HSM 722C +23,5 8217920508 PMMA HSM 722C +28,5 8221020508 CeeOn¿ One-Piece PMMA 722Y, 2 lenses PMMA HSM 722Y +29,0 8136600508 8136610508 CeeOn¿ One-Piece PMMA 811C, 1 lens PMMA HSM 811C +22,0 8054190508 CeeOn¿ One-Piece PMMA 812CU, 4 lenses PMMA HSM 812CU+17,5 8139760508 PMMA HSM 812CU+23,0 8156200508 8156210508 8156220508
- 510(k) numbers
- not on file
- PMA numbers
- ["P960034"]
- 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