Z-0096-06

CeeOn Heparin Surface Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C...

Name: Z-0096-06 CeeOn Heparin Surface Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C...
Creator: Advanced Medical Optics, Inc.
Published: 2005-10-05
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2005-10-05 / Terminated / root cause: packaging

FDA source

Advanced Medical Optics, Inc. began a recall of CeeOn Heparin Surface Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU) on 2005-10-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0096-06
Status: Terminated
Initiated: 2005-10-05
Posted: 2005-10-28
Terminated: 2008-05-23
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)
Product code: HQL Intraocular Lens
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 45 (4 in US)
Distribution: Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam
Product codes and lots: 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

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)